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FDA 510(k)

GAMMA-GLUTAMYL TRANSFERASE

K-Number: K881626 · 1988-05-27

ApplicantTech-Co, Inc.
Decision Date1988-05-27
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-GLUTAMYL TRANSFERASE is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-05-27 under 510(k) number K881626. 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 GAMMA-GLUTAMYL TRANSFERASE?

GAMMA-GLUTAMYL TRANSFERASE is a medical device that received FDA 510(k) clearance on 1988-05-27. The listed applicant is Tech-Co, Inc.. The 510(k) number is K881626.

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

GAMMA-GLUTAMYL TRANSFERASE received FDA 510(k) clearance on 1988-05-27, under 510(k) number K881626.

Who is the listed applicant for GAMMA-GLUTAMYL TRANSFERASE?

The FDA 510(k) record lists Tech-Co, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA-GLUTAMYL TRANSFERASE?

The FDA product code for GAMMA-GLUTAMYL TRANSFERASE is JQB.

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Other records listing Tech-Co, Inc. 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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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