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510(k) K924246

Device
Roche Reagent For Ggt
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
510(k) number
K924246
Product code
JQB
Decision
Substantially Equivalent (SESE)
Decision date
1992-11-18
Date received
1992-08-24
Regulation
862.1360
Classification name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CAROL L KRIEGER
Address
1080 Us Hwy. 202 Branchburg NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JQB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.1997-11-04
K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,1997-10-10
K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.1997-05-06
K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.1997-01-13
K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.1997-01-10
K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, Inc.1996-09-09
K945800Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05Diagnostic Chemicals , Ltd.1995-06-09
K946192HICHEM Y-GT REAGENT KITHichem Diagnostics1995-05-02
K942962GGT QVETPrisma Systems1994-12-07
K935984GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419Sigma Diagnostics, Inc.1994-07-20
K941315STANBIO Y-GT (LIQUICOLOR) TEST SETStanbio Laboratory1994-07-14
K935177GAMMA-GLUTAMYL TRANSFERASE (GGT) TESTEm Diagnostic Systems, Inc.1993-12-16
K931958SYNERMED GGT REAGENT KITSynermed, Inc.1993-09-08
K925337OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENTOlympus Corp.1993-01-26
K922947GAMMA GULTAMYL TRANSFERASE TESTEm Diagnostic Systems, Inc.1992-09-28