FDA.reportPublic FDA data

510(k) K771628

Device
NSULIN RIA KIT 125I
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) number
K771628
Product code
CFP
Decision
Substantially Equivalent (SESE)
Decision date
1977-09-20
Date received
1977-08-26
Regulation
862.1405
Classification name
Radioimmunoassay, Immunoreactive Insulin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CFP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963911ALPCO/MERCODIA INSULIN ELISAAmerican Laboratory Products Co., Ltd.1996-11-01
K953084ACCESS ULTRASENSITIVE INSULIN ASSAYBio-Rad Laboratories, Inc.1995-09-25
K920109IMX INSULINAbbott Laboratories1992-05-07
K914820DSL INSULIN RIA (DSL 1600)Diagnostic Systems Laboratories, Inc.1992-01-09
K903628AIA-PACK IRITosoh Corp.1990-09-07
K901135ENZYMUN TEST(R) INSULINBoehringer Mannheim Corp.1990-04-03
K896572REP(TM) SPE PLUS-30 PROCEDURESHelena Laboratories1990-01-11
K890837RIA-GNOST INSULINCambridge Medical Technology1989-04-26
K851071PHARMACIA INSULIN RIAPharmacia, Inc.1985-04-12
K841573INSULIN RADIOIMMUNOASSAY KITSorin Biomedica, Fiat, USA, Inc.1984-05-16
K823939WAKO INSULIN TESTWako Chemicals USA, Inc.1983-01-28
K822509COVALENT COAT RIA KITImmuchem Corp.1982-09-28
K821861COAT-A-COUNT INSULIN KITDiagnostic Products Corp.1982-07-08
K821374ENZYMUNE-TEST INSULINIcl Scientific1982-05-28
K812227GAMMACOAT (125) INSULIN RADIOIMMUNOASSAYClinical Assays, Inc.1981-09-24