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FDA 510(k)

GAMMA GLUTAMY TRANSPEPTIDASE

K-Number: K812296 · 1981-08-31

ApplicantPointe Scientific, Inc.,
Decision Date1981-08-31
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA GLUTAMY TRANSPEPTIDASE is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812296. 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 GLUTAMY TRANSPEPTIDASE?

GAMMA GLUTAMY TRANSPEPTIDASE is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K812296.

When did GAMMA GLUTAMY TRANSPEPTIDASE receive FDA 510(k) clearance?

GAMMA GLUTAMY TRANSPEPTIDASE received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812296.

Who is the listed applicant for GAMMA GLUTAMY TRANSPEPTIDASE?

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

What is the FDA product code for GAMMA GLUTAMY TRANSPEPTIDASE?

The FDA product code for GAMMA GLUTAMY TRANSPEPTIDASE is JQB.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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