FDA 510(k) Applications for Medical Device Product Code "CFP"
(Radioimmunoassay, Immunoreactive Insulin)

FDA 510(k) Number Applicant Device Name Decision Date
K920109 ABBOTT LABORATORIES IMX INSULIN 05/07/1992
K963911 AMERICAN LABORATORY PRODUCTS CO., LTD. ALPCO/MERCODIA INSULIN ELISA 11/01/1996
K811144 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ARIA II INSULIN RIA 05/15/1981
K771628 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC NSULIN RIA KIT 125I 09/20/1977
K953084 BIO-RAD LABORATORIES, INC. ACCESS ULTRASENSITIVE INSULIN ASSAY 09/25/1995
K901135 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) INSULIN 04/03/1990
K890837 CAMBRIDGE MEDICAL TECHNOLOGY RIA-GNOST INSULIN 04/26/1989
K812227 CLINICAL ASSAYS, INC. GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY 09/24/1981
K811953 CORNING MEDICAL & SCIENTIFIC IMMOPHASE INSULIN (125I) RADIOASSAY 07/23/1981
K821861 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT INSULIN KIT 07/08/1982
K914820 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL INSULIN RIA (DSL 1600) 01/09/1992
K790630 ENDOCRINE-METABOLIC CENTER RIA, INSULIN, DOUBLE ANTIBODY 07/24/1979
K896572 HELENA LABORATORIES REP(TM) SPE PLUS-30 PROCEDURES 01/11/1990
K821374 ICL SCIENTIFIC ENZYMUNE-TEST INSULIN 05/28/1982
K822509 IMMUCHEM CORP. COVALENT COAT RIA KIT 09/28/1982
K771947 INTER SCIENCE INSTITUTE INSULIN RIA MODULE 01/20/1978
K792279 MICROMEDIC SYSTEMS AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM 12/06/1979
K781086 MICROMEDIC SYSTEMS INSULIN AUTOPAK 08/14/1978
K851071 PHARMACIA, INC. PHARMACIA INSULIN RIA 04/12/1985
K772281 RADIOASSAY SYSTEMS LABORATORIES, INC. RSL INSULIN KIT 01/06/1978
K781285 SERONO LABORATORIES, INC. INSULIN RIA KIT 08/14/1978
K841573 SORIN BIOMEDICA, FIAT, USA, INC. INSULIN RADIOIMMUNOASSAY KIT 05/16/1984
K903628 TOSOH CORP. AIA-PACK IRI 09/07/1990
K771979 UNION CARBIDE CORP. CENTRIA INSULIN RIA 11/17/1977
K791707 VENTREX LABORATORIES, INC. CENTRIA INSULIN RIA 10/17/1979
K811423 VENTREX LABORATORIES, INC. VENTRE/SEP 06/09/1981
K823939 WAKO CHEMICALS, USA, INC. WAKO INSULIN TEST 01/28/1983


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