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FDA 510(k)

GGT REAGENT

K-Number: K905618 · 1991-02-26

ApplicantAmresco, Inc.
Decision Date1991-02-26
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GGT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K905618. 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 GGT REAGENT?

GGT REAGENT is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Amresco, Inc.. The 510(k) number is K905618.

When did GGT REAGENT receive FDA 510(k) clearance?

GGT REAGENT received FDA 510(k) clearance on 1991-02-26, under 510(k) number K905618.

Who is the listed applicant for GGT REAGENT?

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

What is the FDA product code for GGT REAGENT?

The FDA product code for GGT REAGENT is JPZ.

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Other records listing Amresco, 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.

K904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116K905096GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138

View all 39 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.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, Inc.K901090ELITECH GAMMA GT TEST KITElite Technology, 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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