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510(k) K925337

Device
Olympus Gamma Glutamyl Transferase Reagent
Applicant
OLYMPUS CORP.
510(k) number
K925337
Product code
JQB
Decision
Substantially Equivalent (SESE)
Decision date
1993-01-26
Date received
1992-10-20
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
LAURA STORMS-TYLER
Address
4 Nevada Dr. Lake Success NY US 11042 11042

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
K924246ROCHE REAGENT FOR GGTRoche Diagnostic Systems, Inc.1992-11-18
K922947GAMMA GULTAMYL TRANSFERASE TESTEm Diagnostic Systems, Inc.1992-09-28