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FDA 510(k)

G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT

K-Number: K860723 · 1986-04-07

ApplicantTrace Scientific , Ltd.
Decision Date1986-04-07
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K860723. The device is classified under product code JPZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT?

G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K860723.

When did G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT receive FDA 510(k) clearance?

G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860723.

Who is the listed applicant for G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT?

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

What is the FDA product code for G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT?

The FDA product code for G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT is JPZ.

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Other records listing Trace Scientific , 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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Related Devices (Code: JPZ)

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.

K020486CARESIDE GGTCareside, Inc.K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.K923509GAMMA-GTRandox Laboratories, Ltd.K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.K905618GGT REAGENTAmresco, Inc.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, 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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