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FDA 510(k)

BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST

K-Number: K881311 · 1988-04-28

ApplicantBiotrol, USA, Inc.
Decision Date1988-04-28
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K881311. 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 BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST?

BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K881311.

When did BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST receive FDA 510(k) clearance?

BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST received FDA 510(k) clearance on 1988-04-28, under 510(k) number K881311.

Who is the listed applicant for BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST?

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

What is the FDA product code for BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST?

The FDA product code for BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST is JQB.

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Other records listing Biotrol, USA, Inc. as applicant

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K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK921677BIOTROL MAGNESIUM (MAGON)K912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDS

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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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