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FDA 510(k)

LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET

K-Number: K973157 · 1997-10-10

ApplicantPointe Scientific, Inc.,
Decision Date1997-10-10
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET 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 1997-10-10 under 510(k) number K973157. 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 LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET?

LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K973157.

When did LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET receive FDA 510(k) clearance?

LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET received FDA 510(k) clearance on 1997-10-10, under 510(k) number K973157.

Who is the listed applicant for LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET?

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 LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET?

The FDA product code for LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET 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.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.K945800Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05Diagnostic Chemicals , Ltd.

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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