FDA 510(k) Applications Received During June, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K760104 06/23/1976 RESPIRATION MONITOR AIR-SHIELDS, INC.
K760124 06/28/1976 AUTO CELL DILUENT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760123 06/28/1976 AUTOZYME BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760042 06/15/1976 BLOOD TUBING SETS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760054 06/16/1976 CULTURE TUBE, (VACUTAINER) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760041 06/15/1976 FILTER, RESPIRATORY (U-MID) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760045 06/15/1976 KIT, RADIOASSAY, SERUM IRON BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760044 06/15/1976 KIT, RIA, HUMAN THYROID HORMONE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760063 06/16/1976 SPECIMEN COLLECTOR, ANAEROBIC BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760040 06/15/1976 TEST, MONO., CARD (MACRO-VUE) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760043 06/15/1976 TEST, RHEUM. ARTH., CARD (MACRO-VUE) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760039 06/15/1976 VALVE, I.M.V. (U-MID ONE WAY) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760073 06/18/1976 BASIN, WASH, 6-QT RECTANGULAR BEMIS HEALTH CARE
K760072 06/18/1976 CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR BEMIS HEALTH CARE
K760071 06/18/1976 TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 BEMIS HEALTH CARE
K760070 06/18/1976 TUMBLER, PERSONAL, ROUND, 9 OUNCE BEMIS HEALTH CARE
K760134 06/28/1976 PROCEDURE, RA, THYROXINE BINDING PROTEIN BIO-RAD
K760133 06/28/1976 PROCEDURE, RED CELL FOLATE ASSAY BIO-RAD
K760135 06/28/1976 TEST, RA, QUANTA-COUNT T-4 BIO-RAD
K760132 06/28/1976 TEST, RIA, TSH QUANTIMUNE BIO-RAD
K760093 06/21/1976 CATHETER, SILICONE FOLEY (BARDEX) C.R. BARD, INC.
K760095 06/21/1976 RESPIRIZOR CAMPILLARY SYSTEMS
K760616 06/14/1976 PROPIOCEPTOR MASSAGER CELLERS RESEARCH, INC.
K760138 06/29/1976 BANDAGE, CEB COTTON ELASTIC CONCO MEDICAL CO.
K760141 06/29/1976 BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC CONCO MEDICAL CO.
K760139 06/29/1976 BANDAGE, E-COTTON ELASTIC CONCO MEDICAL CO.
K760142 06/29/1976 BANDAGE, RAPIDO-LASTIC COTTON/NYLON CONCO MEDICAL CO.
K760140 06/29/1976 BANDAGE, WRINKY-LASTIC ELASTIC GAUZE CONCO MEDICAL CO.
K760105 06/24/1976 BAG, URINE COLLECTION, CLOSED SYSTEM CONCORD LABORATORIES, INC.
K760085 06/21/1976 BASIN, STERILE (#3200) CONCORD LABORATORIES, INC.
K760086 06/21/1976 TRAY, BLOOD SAMPLING (PULSATOR II) CONCORD LABORATORIES, INC.
K760128 06/28/1976 TRAY, CATHETERIZATION W/ CATHETER CONCORD LABORATORIES, INC.
K760127 06/28/1976 TRAY, CATHETERIZATION W/O CATHETER CONCORD LABORATORIES, INC.
K760013 06/10/1976 PACER SYSTEMS ANALYZER (CORDIS) CORDIS CORP.
K760076 06/18/1976 ABSORBER, ANESTHESIA CIRCLE SYS, CO2 FRASER SWEATMAN, INC.
K760097 06/14/1976 FEBRILE ANTIGENS & CONTROL SERUMS GAMMA BIOLOGICALS, INC.
K760096 06/14/1976 REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O GAMMA BIOLOGICALS, INC.
K760098 06/14/1976 REAGENT, VDRL GAMMA BIOLOGICALS, INC.
K760033 06/14/1976 TEST, ANTIBODIES FOR GRP A, LATEX SLIDE GAMMA BIOLOGICALS, INC.
K760035 06/14/1976 TEST, C-REATIVE PROTEIN, LATEX SLIDE GAMMA BIOLOGICALS, INC.
K760036 06/14/1976 TEST, LATEX SLIDE, RHEUMATOID FACTOR GAMMA BIOLOGICALS, INC.
K760032 06/14/1976 TEST, MONO., DIFFERENTIAL SLIDE GAMMA BIOLOGICALS, INC.
K760034 06/14/1976 TEST, STREP, LATEX SLIDE GAMMA BIOLOGICALS, INC.
K760007 06/08/1976 BLOOD-SMEARING INSTRUMENT (MINIPREP TM) GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K760030 06/14/1976 CLINICARD PHOSPHORUS HARLECO
K760028 06/14/1976 CPK - ISOENZYMES HARLECO
K760027 06/14/1976 DSP - STAIN PACK HARLECO
K760029 06/14/1976 ENZYMATIC TRIGLYCERIDE HARLECO
K760031 06/14/1976 HISTOCHEMICAL PAS REACTION SET HARLECO
K760129 06/28/1976 SALINE, ISOTONIC BUFFERED, AZIDE-FREE HARLECO
K760024 06/14/1976 ULTRAZYME ALKALINE PHOSPHATASE HARLECO
K760026 06/14/1976 ULTRAZYME AMYLASE HARLECO
K760025 06/14/1976 ULTRAZYME GT HARLECO
K760023 06/14/1976 ULTRAZYME HBD HARLECO
K760089 06/21/1976 TEST, IN-VITRO DIAGNOSTIC HOFFMANN-LA ROCHE, INC.
K760082 06/21/1976 BOTTLE, CONDENSATE (#1628) INSPIRON CORP.
K760080 06/21/1976 CANNULA, NASAL, FOR OXYGEN INSPIRON CORP.
K760081 06/21/1976 FILTER, BACTERIA (#2290) INSPIRON CORP.
K760037 06/15/1976 HEATER, IMMERSION W/ HUMIDIFIER & NEBUL. INSPIRON CORP.
K760064 06/16/1976 CATHETER, THERMAL DILUTION, ANIMAL & PED INSTRUMENTATION LABORATORY CO.
K760067 06/16/1976 CATHETER, THERMAL DILUTION, OPEN CHEST INSTRUMENTATION LABORATORY CO.
K760065 06/16/1976 CATHETER, THERMAL DILUTION, PEDIATRIC INSTRUMENTATION LABORATORY CO.
K760119 06/25/1976 SAMPLER, FLAMELESS (IL MODEL 555) INSTRUMENTATION LABORATORY CO.
K760066 06/16/1976 TRAY, ICED INJECTABLE (26420) INSTRUMENTATION LABORATORY CO.
K760075 06/18/1976 KIT, METHADONE (TOXI-PAK IMMUNO HI) J.T. BAKER CHEMICAL CO.
K760074 06/18/1976 KIT, MORPHINE (TOXI-PAK IMMUNO HI) J.T. BAKER CHEMICAL CO.
K760103 06/23/1976 CAP, INJECTION (#4600) JELCO LABORATORIES
K760110 06/24/1976 FILTER, I.V. (#4700) JELCO LABORATORIES
K760111 06/24/1976 FILTER, I.V., WITH FLASH BULB (#4701) JELCO LABORATORIES
K760022 06/14/1976 NEEDLE, FILTER JELCO LABORATORIES
K760019 06/11/1976 VACUUM TUBES, PEDIATRIC SIZES (J-VAC) JELCO LABORATORIES
K760018 06/11/1976 VACUUM TUBES, STERILE (J-VAC) JELCO LABORATORIES
K760118 06/25/1976 THERMOMETER, DIGITAL FEVER (MEDITEMP) JOHNSON & JOHNSON PROFESSIONALS, INC.
K760094 06/21/1976 SPONGE, CURITY WASHED GAUZE KENDALL RESEARCH CENTER
K760008 06/08/1976 DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL KYOCERA INTERNATIONAL, INC.
K760121 06/28/1976 IMPULSE HEAT SEALER LORVIC CORP.
K760052 06/15/1976 KIT, PREP SHAVE M-C IND., INC.
K760047 06/15/1976 TRAY, BLADDER IRRIGATION M-C IND., INC.
K760051 06/15/1976 TRAY, SUTURE REMOVAL M-C IND., INC.
K760048 06/15/1976 TRAY, URETHRAL CATHETERIZATION M-C IND., INC.
K760017 06/11/1976 CONSIOUS SEDATION (ANALOR P-76) MCKESSON CORP.
K760090 06/21/1976 GRAFT, COOLEY GUIDELINE, STERILE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760092 06/21/1976 GRAFT, COOLEY WOVEN VASCULAR, STERILE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760091 06/21/1976 GRAFT, MICROVEL GUIDELINE, STERILE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760087 06/21/1976 TAPE, VASCULAR, 1/4" DACRON MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K760006 06/07/1976 RADIOASSAY, CONCEPT 4 MICROMEDIC SYSTEMS
K760084 06/21/1976 MONITOR, GSR (NB-401) NARCO BIO-SYSTEMS
K760083 06/21/1976 PHYSIOSCOPE NARCO BIO-SYSTEMS
K760068 06/16/1976 KIT, RIA, GENTAMICIN SULF. NEW ENGLAND NUCLEAR
K760088 06/21/1976 ANALYZER, SENTORR BLOOD GAS OHIO MEDICAL PRODUCTS
K760102 06/23/1976 FLOWMETER, P.C., REDESIGNED VERSION OHIO MEDICAL PRODUCTS
K760101 06/23/1976 OXYGEN & RESUSCITATION (HOPE II MODEL) OHIO MEDICAL PRODUCTS
K760149 06/30/1976 CONDUCTIVE ANESTHSIA BREATH. CIRCUIT OMNICON MEDICAL CORP.
K760106 06/24/1976 PROSTHESIS, TOTAL HIP-FEMORAL ORTHOPEDIC EQUIPMENT CO., INC.
K760109 06/24/1976 PROSTHESIS, TOTAL HIP-RASP ORTHOPEDIC EQUIPMENT CO., INC.
K760108 06/24/1976 PROSTHESIS, TOTAL HIP-TEST CUP ORTHOPEDIC EQUIPMENT CO., INC.
K760107 06/24/1976 PROSTHESIS, TOTAL HIP-TEST FEMORAL ORTHOPEDIC EQUIPMENT CO., INC.
K760078 06/18/1976 REAGENT, RIA TRIIODOTHYRONINE T3 (#200) OXFORD LABORATORIES, INC.
K760079 06/18/1976 REAGENT, THYROXINE T4 (#210) OXFORD LABORATORIES, INC.
K760143 06/29/1976 SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN OXFORD LABORATORIES, INC.
K760148 06/29/1976 SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN OXFORD LABORATORIES, INC.
K760144 06/29/1976 SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760146 06/29/1976 SERUM, IGA GOAT ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760145 06/29/1976 SERUM, IGG GOAT ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760147 06/29/1976 SERUM, IGM ANTI-HUMAN ACID OXFORD LABORATORIES, INC.
K760113 06/24/1976 SPONGE, LAPAROTOMY GAUZE PARKE-DAVIS CO.
K760016 06/11/1976 SURGICAL BLADES (BEAVER) PARKE-DAVIS CO.
K760069 06/16/1976 BAG, LEG, URINE COLLECTING DEVICE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K760125 06/28/1976 AIRWAY, ARGYLE NASOPHARYNGEAL SHERWOOD MEDICAL INDUSTRIES
K760163 06/30/1976 CATHETER, INTRAVASCULAR (MEDICUT T) SHERWOOD MEDICAL INDUSTRIES
K760136 06/28/1976 CATHETER, THORACIC DRAIN SHERWOOD MEDICAL INDUSTRIES
K760137 06/28/1976 TUBE, FEEDING, ARGYLE SHERWOOD MEDICAL INDUSTRIES
K760131 06/28/1976 AGARO-GEL, PRODUCT # A1266 SIGMA CHEMICAL CO.
K760055 06/16/1976 REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER SMITH KLINE DIAGNOSTICS, INC.
K760077 06/18/1976 TEST, RIA, SERUM DIGOXIN SMITH KLINE DIAGNOSTICS, INC.
K760057 06/16/1976 TEST, RIA, TRIODOTHYRONINE SMITH KLINE DIAGNOSTICS, INC.
K760120 06/28/1976 PULSE CARDULE (MODEL 1859/1860 ECG) SPACELABS, INC.
K760004 06/07/1976 SYRINGE, DISPOSABLE, ALL PLASTIC STEWART-NAUMANN LABORATORIES
K760005 06/07/1976 SYRINGE, DISPOSABLE, GLASS & PLASTIC STEWART-NAUMANN LABORATORIES
K760009 06/10/1976 COLORIMETRIC DETERMINATION (LDH) THE DOW CHEMICAL CO.
K760010 06/10/1976 COLORIMETRIC DETERMINATION (SGOT/SGPT) THE DOW CHEMICAL CO.
K760011 06/10/1976 REAGENT, TRIGLYCERIDES THE DOW CHEMICAL CO.
K760112 06/24/1976 SPECTROPHOTOMETER (JUNIOR III) THE PERKIN-ELMER CORP.
K760046 06/15/1976 CASE, CONTACT LENS, PLASTIC TOMLIN B. HORSLEY, JR.
K760012 06/10/1976 BLOOD WARMER (CODE 4R4305) TRAVENOL LABORATORIES, S.A.
K760126 06/28/1976 LENS, HARD CONTACT TRU-FORM OPTICS, INC.
K760130 06/28/1976 PROSTHESIS, VASCULAR BIFURCATED USCI, DIV. C.R. BARD, INC.
K760122 06/28/1976 WILL-CERAM Y-2 WILLIAMS GOLD REFINING CO., INC.


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