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FDA 510(k)

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)

K-Number: K803089 · 1981-01-02

ApplicantEnvironmental Chemical Specialties
Decision Date1981-01-02
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Chemical Specialties. It received FDA 510(k) clearance on 1981-01-02 under 510(k) number K803089. 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 GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)?

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) is a medical device that received FDA 510(k) clearance on 1981-01-02. The listed applicant is Environmental Chemical Specialties. The 510(k) number is K803089.

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

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) received FDA 510(k) clearance on 1981-01-02, under 510(k) number K803089.

Who is the listed applicant for GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)?

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

What is the FDA product code for GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)?

The FDA product code for GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) is JPZ.

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Other records listing Environmental Chemical Specialties 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.

K812635ANEMIA CONTROLK811810URIC ACID TESTK811809ANTI-ARRHYTHMIC CONTROL LEVELS I & IIK811811TDM ANTI-CONVULSANT CONTROL LEVELS I-IIK792377CARCINOEMBRYONIC ANTIGEN (CEA) CONTROLK801854SPINAL FLUID CONTROL(HUMAN)

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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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