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510(k) K823090

Device
RAICHEM & GT REAGENT
Applicant
REAGENTS APPLICATIONS, INC.
510(k) number
K823090
Product code
JPZ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-22
Date received
1982-10-19
Regulation
862.1360
Classification name
Colorimetric Method, Gamma-glutamyl Transpeptidase
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 JPZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K020486CARESIDE GGTCareside, Inc.2002-07-01
K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.1996-07-01
K923509GAMMA-GTRandox Laboratories, Ltd.1992-12-03
K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.1992-09-09
K905618GGT REAGENTAmresco, Inc.1991-02-26
K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, Inc.1990-10-12
K901090ELITECH GAMMA GT TEST KITElite Technology, Inc.1990-03-29
K895984WAKO(TM) AUTOKIT GAMMA-GTWako Chemicals USA, Inc.1989-11-08
K881239GAMMA GLUTAMYL TRANSFERASE REAGENT SETTech-Neal Scientific, Inc.1988-05-31
K874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)Simmler, Inc.1988-02-11
K871979GAMMA GLUTAMYLTRANSFERASE REAGENTIntersect Systems, Inc.1987-06-11
K864208VISION (TM) GGTPAbbott Laboratories1986-11-24
K863586GAMMA GLUTAMYL TRANSFERASE PROCEDUREData Medical Associates, Inc.1986-10-03
K861672GAMMA GLUTAMYL TRANSFERASE PROCEDUREData Medical Associates, Inc.1986-05-29
K860723G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENTTrace Scientific , Ltd.1986-04-07

Legacy Summary#

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FDA Review#

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