ClearanceBrief
Panels › Clinical Chemistry › Product code CFP · Class 1

Radioimmunoassay, Immunoreactive Insulin

Regulation 862.1405

0510(k)s in 12 months (27 all time)
0recalls in 12 months (8 all time)
5recalls that name a 510(k)
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Top companies in CFP

Decided510(k)Device and applicantCode
Nov 1, 1996K963911ALPCO/MERCODIA INSULIN ELISA
American Laboratory Products Co., Ltd.
CFP
Sep 25, 1995K953084ACCESS ULTRASENSITIVE INSULIN ASSAY
Bio-Rad Laboratories, Inc.
CFP
May 7, 1992K920109IMX INSULIN
Abbott Laboratories
CFP
Jan 9, 1992K914820DSL INSULIN RIA (DSL 1600)
Diagnostic Systems Laboratories, Inc.
CFP
Sep 7, 1990K903628AIA-PACK IRI
Tosoh Corp.
CFP
Apr 3, 1990K901135ENZYMUN TEST(R) INSULIN
Boehringer Mannheim Corp.
CFP
Jan 11, 1990K896572REP(TM) SPE PLUS-30 PROCEDURES
Helena Laboratories
CFP
Apr 26, 1989K890837RIA-GNOST INSULIN
Cambridge Medical Technology
CFP
Apr 12, 1985K851071PHARMACIA INSULIN RIA
Pharmacia, Inc.
CFP
May 16, 1984K841573INSULIN RADIOIMMUNOASSAY KIT
Sorin Biomedica, Fiat, USA, Inc.
CFP
Jan 28, 1983K823939WAKO INSULIN TEST
Wako Chemicals USA, Inc.
CFP
Sep 28, 1982K822509COVALENT COAT RIA KIT
Immuchem Corp.
CFP
Jul 8, 1982K821861COAT-A-COUNT INSULIN KIT
Diagnostic Products Corp.
CFP
May 28, 1982K821374ENZYMUNE-TEST INSULIN
Icl Scientific
CFP
Sep 24, 1981K812227GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
Clinical Assays, Inc.
CFP
Jul 23, 1981K811953IMMOPHASE INSULIN (125I) RADIOASSAY
Corning Medical & Scientific
CFP
Jun 9, 1981K811423VENTRE/SEP
Ventrex Laboratories, Inc.
CFP
May 15, 1981K811144ARIA II INSULIN RIA
Bd Becton Dickinson Vacutainer Systems Preanalytic
CFP
Dec 6, 1979K792279AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM
Micromedic Systems
CFP
Oct 17, 1979K791707CENTRIA INSULIN RIA
Ventrex Laboratories, Inc.
CFP
Jul 24, 1979K790630RIA, INSULIN, DOUBLE ANTIBODY
Endocrine-Metabolic Center
CFP
Aug 14, 1978K781285INSULIN RIA KIT
Serono Laboratories, Inc.
CFP
Aug 14, 1978K781086INSULIN AUTOPAK
Micromedic Systems
CFP
Jan 20, 1978K771947INSULIN RIA MODULE
Inter Science Institute
CFP
Jan 6, 1978K772281RSL INSULIN KIT
Radioassay Systems Laboratories, Inc.
CFP
Nov 17, 1977K771979CENTRIA INSULIN RIA
Union Carbide Corp.
CFP
Sep 20, 1977K771628NSULIN RIA KIT 125I
Bd Becton Dickinson Vacutainer Systems Preanalytic
CFP

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