ABSTRACT

KANAMYCIN SULFATE 520.1204 KANAMYCIN SULFATE, AMINOPENTAMIDE HYDROGEN SULFATE, PECTIN, BISMUTH SUBCARBONATE, ACTIVATED ATTAPULGITE ORAL SUSPENSION Oral Dosage Form New Animal Drugs

KANAMYCIN SULFATE 520.1205 KANAMYCIN SULFATE, PECTIN, BISMUTH SUBCARBONATE, ACTIVATED ATTAPULGITE TABLETS Oral Dosage Form New Animal Drugs

KANAMYCIN SULFATE 522.1204 KANAMYCIN SULFATE INJECTION Implantation Or Injectable Dosage Form New Animal Drugs

KANAMYCIN SULFATE 524.1204 KANAMYCIN SULFATE, CALCIUM AMPHOMYCIN, AND HYDROCORTISONE ACETATE Ophthalmic And Topical Dosage Form New Animal Drugs

KAOLIN 186.1256 CLAY (KAOLIN) Listing Of Specific Substances Affirmed As GRAS; Indirect Food Substances Affirmed As Generally Recognized As Safe

KARAYA 872.3400 KARAYA AND SODIUM BORATE WITH OR WITHOUT ACACIA DENTURE ADHESIVE Prosthetic Devices; Dental Devices

KARAYA 872.3450 ETHYLENE OXIDE HOMOPOLYMER AND/OR KARAYA DENTURE ADHESIVE Prosthetic Devices; Dental Devices

KARAYA GUM 184.1349 KARAYA GUM (STERCULIA GUM) Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe

KARAYA GUM 201.319 WATER-SOLUBLE GUMS, AND HYDROPHILIC MUCILLOIDS (INCLUDING GUAR GUM, KARAYA GUM, XANTHAN GUM) AS ACTIVE INGREDIENTS; WARNINGS AND DIRECTIONS Specific Labeling Requirements For Specific Drug Products; Labeling

KELP 172.365 KELP Special Dietary And Nutritional Additives; Food Additives Permitted For Direct Addition To Food For Human Consumption

KELP 201.319 WATER-SOLUBLE GUMS, AND HYDROPHILIC MUCILLOIDS (INCLUDING KELP) AS ACTIVE INGREDIENTS; WARNINGS AND DIRECTIONS Specific Labeling Requirements For Specific Drug Products; Labeling

KENTUCKY 808.67 KENTUCKY Listing Of Specific State And Local Exemptions; Exemption From Federal Preemption Of State & Local Medical Device Requirements

KERATOLYTIC 346.20 KERATOLYTIC ACTIVE INGREDIENTS Anorectal Drug Products For Over-the-counter Human Use

KERATOME 886.4370 KERATOME Surgical Devices; Ophthalmic Devices

KERATOPROSTHESIS 886.33040 KERATOPROSTHESIS Prosthetic Devices; Ophthalmic Devices

KERATOSCOPE 886.1350 KERATOSCOPE Diagnostic Devices; Ophthalmic Devices

KERNEL, PALM 172.861 COCOA BUTTER SUBSTITUTE FROM COCONUT OIL, PALM KERNEL OIL, OR BOTH OILS Food Additives Permitted For Direct Addition To Food For Human Consumption

KERNEL, TAMARIND SEED 176.350 TAMARIND SEED KERNEL POWDER Substances For Use Only As Components Of Paper And Paperboard; Indirect Food Additives

KETAMINE HYDROCHLORIDE 522.1222 KETAMINE HYDROCHLORIDE INJECTABLE DOSAGE FORMS Implantation Or Injectable Dosage Form New Animal Drugs

KETENE DIMERS 176.120 ALKYL KETENE DIMERS Substances For Use Only As Components Of Paper And Paperboard; Indirect Food Additives

KETOGENIC STEROIDS 862.1385 17-HYDROXYCORTICOSTEROIDS (17-KETOGENIC STEROIDS) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Device

KETONES 862.1435 KETONES (NONQUANTITATIVE) TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

KETOPROFEN 522.1225 KETOPROFEN SOLUTION

Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

KIDNEY 876.5880 ISOLATED KIDNEY PERFUSION AND TRANSPORT SYSTEM AND ACCESSORIES Therapeutic Devices; Gastroenterology-urology Devices

KIIL TYPE INSERT 876.5830 HEMODIALYZER WITH DISPOSABLE INSERT (KIIL TYPE) Therapeutic Devices; Gastroenterology-urology Devices

KINASE 862.1215 CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

KINASE 862.1650 PYRUVATE KINASE TEST SYSTEM Clinical Chemistry Test Systems; Clinical Chemistry And Clinical Toxicology Devices

KIT 864.2260 CHROMOSOME CULTURE KIT Cell And Tissue Culture Products; Hematology And Pathology Devices

KIT 864.9650 QUALITY CONTROL KIT FOR BLOOD BANKING REAGENTS Products Used In Establishments That Manufacture Blood And Blood Products; Hematology And Pathology Devices

KIT 866.2480 QUALITY CONTROL KIT FOR CULTURE MEDIA Microbiology Devices; Immunology And Microbiology Devices

KIT 868.1100 ARTERIAL BLOOD SAMPLING KIT Diagnostic Devices; Anesthesiology Devices

KIT 868.5140 ANESTHESIA CONDUCTION KIT Therapeutic Devices; Anesthesiology Devices

KIT 870.1350 CATHETER BALLOON REPAIR KIT Cardiovascular Diagnostic Devices; Cardiovascular Devices

KIT 872.3570 OTC DENTURE REPAIR KIT Prosthetic Devices; Dental Devices

KIT 872.3600 PARTIALLY FABRICATED DENTURE KIT Prosthetic Devices; Dental Devices

KIT 876.5210 ENEMA KIT Therapeutic Devices; Gastroenterology-urology Devices

KIT 878.3925 PLASTIC SURGERY KIT AND ACCESSORIES Prosthetic Devices; General And Plastic Surgery Devices

KIT 880.5740 SUCTION SNAKEBITE KIT General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices

KIT 880.5760 CHEMICAL COLD PACK SNAKEBITE KIT General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Devices

KIT 880.5960 LICE REMOVAL KIT General Hospital And Personal Use Therapeutic Devices; General Hospital And Personal Use Device

KITS 864.1860 IMMUNOHISTOCHEMISTRY REAGENTS AND KITS Biological Stains; Hematology And Pathology Devices

KNIFE 886.4230 OPHTHALMIC KNIFE TEST DRUM Surgical Devices; Ophthalmic Devices

KLEBSIELLA SPP. 866.3340 KLEBSIELLA SPP. SEROLOGICAL REAGENTS Serological Reagents; Immunology And Microbiology Devices

KLUYVEROMYCES LACTIS 184.1388 LACTASE ENZYME PREPARATION FROM KLUYVEROMYCES LACTIS Listing Of Specific Substances Affirmed As GRAS; Direct Food Substances Affirmed As Generally Recognized As Safe

KNEE JOINT 888.3480 KNEE JOINT FEMOROTIBIAL METALLIC CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3490 KNEE JOINT FEMOROTIBIAL METAL/COMPOSITE NON-CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3500 KNEE JOINT FEMOROTIBIAL METAL/COMPOSITE SEMI-CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3510 KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3520 KNEE JOINT FEMOROTIBIAL METAL/POLYMER NON-CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3530 KNEE JOINT FEMOROTIBIAL METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS

CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3550 KNEE JOINT PATELLOFEMORAL POLYMER/METAL/METAL CONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3560 KNEE JOINT PATELLOFEMORAL POLYMER/METAL/POLYMER SEMICONSTRAINED CEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3570 KNEE JOINT FEMORAL (HEMI-KNEE) METALLIC UNCEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3580 KNEE JOINT PATELLAR (HEMI-KNEE) METALLIC RESURFACING UNCEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KNEE JOINT 888.3590 KNEE JOINT TIBIAL (HEMI-KNEE) METALLIC RESURFACING UNCEMENTED PROSTHESIS Prosthetic Devices; Orthopedic Devices

KOCH KAESE 133.127 COOK CHEESE, KOCH KAESE Requirements For Specific Standardized Cheese And Related Products; Cheeses And Related Cheese Products