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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