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FDA 510(k)

ULTRA ZYME PLUS GAMMA GT #65055 & 56

K-Number: K830308 · 1983-02-28

ApplicantEmd Chemicals, Inc.
Decision Date1983-02-28
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA ZYME PLUS GAMMA GT #65055 & 56 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1983-02-28 under 510(k) number K830308. 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 ULTRA ZYME PLUS GAMMA GT #65055 & 56?

ULTRA ZYME PLUS GAMMA GT #65055 & 56 is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K830308.

When did ULTRA ZYME PLUS GAMMA GT #65055 & 56 receive FDA 510(k) clearance?

ULTRA ZYME PLUS GAMMA GT #65055 & 56 received FDA 510(k) clearance on 1983-02-28, under 510(k) number K830308.

Who is the listed applicant for ULTRA ZYME PLUS GAMMA GT #65055 & 56?

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

What is the FDA product code for ULTRA ZYME PLUS GAMMA GT #65055 & 56?

The FDA product code for ULTRA ZYME PLUS GAMMA GT #65055 & 56 is JQB.

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Other records listing Emd Chemicals, Inc. as applicant

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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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