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FDA 510(k)

GAMMA-GLUTAMYL TRANSPEPTIDASE

K-Number: K964916 · 1997-01-10

ApplicantDerma Media Lab., Inc.
Decision Date1997-01-10
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA-GLUTAMYL TRANSPEPTIDASE is the device name listed in this FDA 510(k) record. The listed applicant is Derma Media Lab., Inc.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K964916. 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 TRANSPEPTIDASE?

GAMMA-GLUTAMYL TRANSPEPTIDASE is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Derma Media Lab., Inc.. The 510(k) number is K964916.

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

GAMMA-GLUTAMYL TRANSPEPTIDASE received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964916.

Who is the listed applicant for GAMMA-GLUTAMYL TRANSPEPTIDASE?

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

What is the FDA product code for GAMMA-GLUTAMYL TRANSPEPTIDASE?

The FDA product code for GAMMA-GLUTAMYL TRANSPEPTIDASE is JQB.

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Other records listing Derma Media Lab., 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.

K971309UREAK970664GLUCOSE REAGENTK971072CHOLESTEROL REAGENTK971005TRIGLYCERIDESK970867URIC ACID REAGENTK964915MAGNESIUM

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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.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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