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FDA 510(k)

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05

K-Number: K945800 · 1995-06-09

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1995-06-09
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1995-06-09 under 510(k) number K945800. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05?

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 is a medical device that received FDA 510(k) clearance on 1995-06-09. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K945800.

When did Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 receive FDA 510(k) clearance?

Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 received FDA 510(k) clearance on 1995-06-09, under 510(k) number K945800.

Who is the listed applicant for Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05?

The FDA product code for Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 is JQB.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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Related Devices (Code: JQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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