Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION

K-Number: K905649 · 1991-01-30

ApplicantBiochemical Trade, Inc.
Decision Date1991-01-30
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K905649. 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-GLUTAMYL TRANSFERASE DETERMINATION?

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K905649.

When did GAMMA-GLUTAMYL TRANSFERASE DETERMINATION receive FDA 510(k) clearance?

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905649.

Who is the listed applicant for GAMMA-GLUTAMYL TRANSFERASE DETERMINATION?

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

What is the FDA product code for GAMMA-GLUTAMYL TRANSFERASE DETERMINATION?

The FDA product code for GAMMA-GLUTAMYL TRANSFERASE DETERMINATION is JQB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biochemical Trade, 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.

K942958CREATINE KINASE MB DETERMINATION (UV)K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905776ALBUMIN REAGENT SETK905790TOTAL PROTEIN REAGENT SETK905650KINETIC ALKALINE PHOSPHATASE DETERMINATION

View all 20 devices →

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.

↑