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FDA 510(k)

GAMMA-GT REAGENT SYSTEM

K-Number: K810434 · 1981-02-26

ApplicantAmerican Monitor Corp.
Decision Date1981-02-26
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-GT REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1981-02-26 under 510(k) number K810434. 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 GAMMA-GT REAGENT SYSTEM?

GAMMA-GT REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1981-02-26. The listed applicant is American Monitor Corp.. The 510(k) number is K810434.

When did GAMMA-GT REAGENT SYSTEM receive FDA 510(k) clearance?

GAMMA-GT REAGENT SYSTEM received FDA 510(k) clearance on 1981-02-26, under 510(k) number K810434.

Who is the listed applicant for GAMMA-GT REAGENT SYSTEM?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA-GT REAGENT SYSTEM?

The FDA product code for GAMMA-GT REAGENT SYSTEM is JQB.

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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