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CFP — Radioimmunoassay, Immunoreactive Insulin Class I

FDA Device Classification

Classification Details

Product Code
CFP
Device Class
Class I
Regulation Number
862.1405
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K963911american laboratory products coALPCO/MERCODIA INSULIN ELISANovember 1, 1996
K953084bio-rad laboratoriesACCESS ULTRASENSITIVE INSULIN ASSAYSeptember 25, 1995
K920109abbott laboratoriesIMX INSULINMay 7, 1992
K914820diagnostic systems laboratoriesDSL INSULIN RIA (DSL 1600)January 9, 1992
K903628tosohAIA-PACK IRISeptember 7, 1990
K901135boehringer mannheimENZYMUN TEST(R) INSULINApril 3, 1990
K896572helena laboratoriesREP(TM) SPE PLUS-30 PROCEDURESJanuary 11, 1990
K890837cambridge medical technologyRIA-GNOST INSULINApril 26, 1989
K851071pharmaciaPHARMACIA INSULIN RIAApril 12, 1985
K841573sorin biomedica, fiat, usaINSULIN RADIOIMMUNOASSAY KITMay 16, 1984
K823939wako chemicals usaWAKO INSULIN TESTJanuary 28, 1983
K822509immuchemCOVALENT COAT RIA KITSeptember 28, 1982
K821861diagnostic productsCOAT-A-COUNT INSULIN KITJuly 8, 1982
K821374icl scientificENZYMUNE-TEST INSULINMay 28, 1982
K812227clinical assaysGAMMACOAT (125) INSULIN RADIOIMMUNOASSAYSeptember 24, 1981
K811953corning medical and scientificIMMOPHASE INSULIN (125I) RADIOASSAYJuly 23, 1981
K811423ventrex laboratoriesVENTRE/SEPJune 9, 1981
K811144bd becton dickinson vacutainer systems preanalyticARIA II INSULIN RIAMay 15, 1981
K792279micromedic systemsAUTOPAK 12 INSULIN TEST DELIVERY SYSTEMDecember 6, 1979
K791707ventrex laboratoriesCENTRIA INSULIN RIAOctober 17, 1979