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 |