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510(k) K812227

Device
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
Applicant
CLINICAL ASSAYS, INC.
510(k) number
K812227
Product code
CFP  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-24
Date received
1981-08-10
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
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K811953IMMOPHASE INSULIN (125I) RADIOASSAYCorning Medical & Scientific1981-07-23

Legacy Summary#

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FDA Review#

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