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FDA 510(k)

HICHEM Y-GT REAGENT KIT

K-Number: K946192 · 1995-05-02

ApplicantHichem Diagnostics
Decision Date1995-05-02
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM Y-GT REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K946192. 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 HICHEM Y-GT REAGENT KIT?

HICHEM Y-GT REAGENT KIT is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Hichem Diagnostics. The 510(k) number is K946192.

When did HICHEM Y-GT REAGENT KIT receive FDA 510(k) clearance?

HICHEM Y-GT REAGENT KIT received FDA 510(k) clearance on 1995-05-02, under 510(k) number K946192.

Who is the listed applicant for HICHEM Y-GT REAGENT KIT?

The FDA 510(k) record lists Hichem Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HICHEM Y-GT REAGENT KIT?

The FDA product code for HICHEM Y-GT REAGENT KIT is JQB.

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Other records listing Hichem Diagnostics 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.

K981794HICHEM CALCIUM REAGENT KITK963383HICHEM ALP/AMP REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K953863HICHEM ISE STANDARDS KIT 70011

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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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