CFP · Class I · 21 CFR 862.1405

FDA Product Code CFP: Radioimmunoassay, Immunoreactive Insulin

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Micromedic Systems and Ventrex Laboratories, Inc..

27
Total
27
Cleared
43d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Immunoreactive Insulin Devices (Product Code CFP)

27 devices
1–24 of 27
Cleared Nov 01, 1996
ALPCO/MERCODIA INSULIN ELISA
K963911
American Laboratory Products Co., Ltd.
Chemistry · 32d
Cleared Sep 25, 1995
ACCESS ULTRASENSITIVE INSULIN ASSAY
K953084
Bio-Rad Laboratories, Inc.
Chemistry · 84d
Cleared May 07, 1992
IMX INSULIN
K920109
Abbott Laboratories
Chemistry · 118d
Cleared Jan 09, 1992
DSL INSULIN RIA (DSL 1600)
K914820
Diagnostic Systems Laboratories, Inc.
Chemistry · 76d
Cleared Apr 03, 1990
ENZYMUN TEST(R) INSULIN
K901135
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Jan 11, 1990
REP(TM) SPE PLUS-30 PROCEDURES
K896572
Helena Laboratories
Chemistry · 52d
Cleared Apr 12, 1985
PHARMACIA INSULIN RIA
K851071
Pharmacia, Inc.
Chemistry · 25d
Cleared Jan 28, 1983
WAKO INSULIN TEST
K823939
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Jul 08, 1982
COAT-A-COUNT INSULIN KIT
K821861
Diagnostic Products Corp.
Chemistry · 14d
Cleared May 28, 1982
ENZYMUNE-TEST INSULIN
K821374
Icl Scientific
Chemistry · 18d
Cleared Jul 23, 1981
IMMOPHASE INSULIN (125I) RADIOASSAY
K811953
Corning Medical & Scientific
Hematology · 15d
Cleared Jun 09, 1981
VENTRE/SEP
K811423
Ventrex Laboratories, Inc.
Chemistry · 19d
Cleared May 15, 1981
ARIA II INSULIN RIA
K811144
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 18d
Cleared Dec 06, 1979
AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM
K792279
Micromedic Systems
Chemistry · 23d
Cleared Oct 17, 1979
CENTRIA INSULIN RIA
K791707
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Aug 14, 1978
INSULIN AUTOPAK
K781086
Micromedic Systems
Toxicology · 46d
Cleared Nov 17, 1977
CENTRIA INSULIN RIA
K771979
Union Carbide Corp.
Immunology · 31d
Cleared Sep 20, 1977
NSULIN RIA KIT 125I
K771628
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 25d

About Product Code CFP - Regulatory Context