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FDA 510(k)

GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138

K-Number: K905096 · 1990-11-28

ApplicantAmresco, Inc.
Decision Date1990-11-28
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1990-11-28 under 510(k) number K905096. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138?

GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 is a medical device that received FDA 510(k) clearance on 1990-11-28. The listed applicant is Amresco, Inc.. The 510(k) number is K905096.

When did GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 receive FDA 510(k) clearance?

GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 received FDA 510(k) clearance on 1990-11-28, under 510(k) number K905096.

Who is the listed applicant for GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138?

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 REAGENTS, 7738, 7739, 7538, 7438 & 7138?

The FDA product code for GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 is JQB.

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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.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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Related Devices (Code: JQB)

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.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, 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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