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FDA 510(k)

GAMMA GLUTAMYL TRANSFERASE REAGENT SET

K-Number: K881239 · 1988-05-31

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-05-31
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA GLUTAMYL TRANSFERASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K881239. 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 TRANSFERASE REAGENT SET?

GAMMA GLUTAMYL TRANSFERASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K881239.

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

GAMMA GLUTAMYL TRANSFERASE REAGENT SET received FDA 510(k) clearance on 1988-05-31, under 510(k) number K881239.

Who is the listed applicant for GAMMA GLUTAMYL TRANSFERASE REAGENT SET?

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

What is the FDA product code for GAMMA GLUTAMYL TRANSFERASE REAGENT SET?

The FDA product code for GAMMA GLUTAMYL TRANSFERASE REAGENT SET is JPZ.

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Other records listing Tech-Neal Scientific, 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.

K882256MAGNESIUM REAGENT SETK882459DIAZO, COLORIMETRIC BILIRUBINK881241TOTAL BILIRUBIN REAGENTK881237CREATINE KINASE (CK) REAGENT SETK881240CHLORIDE REAGENT SETK880237CHOLESTEROL

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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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