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FDA 510(k)

GLUTAMYLTRANSFERASE ASSAY KIT

K-Number: K850788 · 1985-03-19

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1985-03-19
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUTAMYLTRANSFERASE ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1985-03-19 under 510(k) number K850788. 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 GLUTAMYLTRANSFERASE ASSAY KIT?

GLUTAMYLTRANSFERASE ASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-03-19. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K850788.

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

GLUTAMYLTRANSFERASE ASSAY KIT received FDA 510(k) clearance on 1985-03-19, under 510(k) number K850788.

Who is the listed applicant for GLUTAMYLTRANSFERASE ASSAY KIT?

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

What is the FDA product code for GLUTAMYLTRANSFERASE ASSAY KIT?

The FDA product code for GLUTAMYLTRANSFERASE ASSAY KIT is JPZ.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

View all 77 devices →

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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