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FDA 510(k)

GAMMA GLUTAMYLTRANSFERASE REAGENT

K-Number: K871979 · 1987-06-11

ApplicantIntersect Systems, Inc.
Decision Date1987-06-11
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA GLUTAMYLTRANSFERASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871979. 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 GLUTAMYLTRANSFERASE REAGENT?

GAMMA GLUTAMYLTRANSFERASE REAGENT is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K871979.

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

GAMMA GLUTAMYLTRANSFERASE REAGENT received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871979.

Who is the listed applicant for GAMMA GLUTAMYLTRANSFERASE REAGENT?

The FDA 510(k) record lists Intersect Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA GLUTAMYLTRANSFERASE REAGENT?

The FDA product code for GAMMA GLUTAMYLTRANSFERASE REAGENT is JPZ.

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Other records listing Intersect Systems, 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.

K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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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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