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FDA 510(k)

ULTRAZYME PLUS GAMMA GT-MCA #65055-65056

K-Number: K830240 · 1983-02-18

ApplicantEmd Chemicals, Inc.
Decision Date1983-02-18
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 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 1983-02-18 under 510(k) number K830240. 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 ULTRAZYME PLUS GAMMA GT-MCA #65055-65056?

ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K830240.

When did ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 receive FDA 510(k) clearance?

ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830240.

Who is the listed applicant for ULTRAZYME PLUS GAMMA GT-MCA #65055-65056?

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 ULTRAZYME PLUS GAMMA GT-MCA #65055-65056?

The FDA product code for ULTRAZYME PLUS GAMMA GT-MCA #65055-65056 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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