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FDA 510(k)

OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT

K-Number: K925337 · 1993-01-26

ApplicantOlympus Corp.
Decision Date1993-01-26
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1993-01-26 under 510(k) number K925337. 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 OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT?

OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT is a medical device that received FDA 510(k) clearance on 1993-01-26. The listed applicant is Olympus Corp.. The 510(k) number is K925337.

When did OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT receive FDA 510(k) clearance?

OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT received FDA 510(k) clearance on 1993-01-26, under 510(k) number K925337.

Who is the listed applicant for OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT?

The FDA 510(k) record lists Olympus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT?

The FDA product code for OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT is JQB.

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Other records listing Olympus Corp. 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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