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FDA 510(k)

RAICHEM GGT REAGENT

K-Number: K905085 · 1990-12-20

ApplicantReagents Applications, Inc.
Decision Date1990-12-20
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM GGT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1990-12-20 under 510(k) number K905085. 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 RAICHEM GGT REAGENT?

RAICHEM GGT REAGENT is a medical device that received FDA 510(k) clearance on 1990-12-20. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K905085.

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

RAICHEM GGT REAGENT received FDA 510(k) clearance on 1990-12-20, under 510(k) number K905085.

Who is the listed applicant for RAICHEM GGT REAGENT?

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

What is the FDA product code for RAICHEM GGT REAGENT?

The FDA product code for RAICHEM GGT REAGENT is JQB.

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Other records listing Reagents Applications, Inc. as applicant

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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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