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FDA 510(k)

ASSAY FOR GAMMA GLUTAMYLTRANSFERASE

K-Number: K760346 · 1976-10-27

ApplicantPrinceton Biomedix
Decision Date1976-10-27
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSAY FOR GAMMA GLUTAMYLTRANSFERASE is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1976-10-27 under 510(k) number K760346. 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 ASSAY FOR GAMMA GLUTAMYLTRANSFERASE?

ASSAY FOR GAMMA GLUTAMYLTRANSFERASE is a medical device that received FDA 510(k) clearance on 1976-10-27. The listed applicant is Princeton Biomedix. The 510(k) number is K760346.

When did ASSAY FOR GAMMA GLUTAMYLTRANSFERASE receive FDA 510(k) clearance?

ASSAY FOR GAMMA GLUTAMYLTRANSFERASE received FDA 510(k) clearance on 1976-10-27, under 510(k) number K760346.

Who is the listed applicant for ASSAY FOR GAMMA GLUTAMYLTRANSFERASE?

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

What is the FDA product code for ASSAY FOR GAMMA GLUTAMYLTRANSFERASE?

The FDA product code for ASSAY FOR GAMMA GLUTAMYLTRANSFERASE is JPZ.

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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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