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FDA 510(k)

ULTRAZYME PLUS-GT, #64959 & 65032

K-Number: K821468 · 1982-06-02

ApplicantEmd Chemicals, Inc.
Decision Date1982-06-02
Product CodeJPZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS-GT, #64959 & 65032 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 1982-06-02 under 510(k) number K821468. The device is classified under product code JPZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS-GT, #64959 & 65032?

ULTRAZYME PLUS-GT, #64959 & 65032 is a medical device that received FDA 510(k) clearance on 1982-06-02. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K821468.

When did ULTRAZYME PLUS-GT, #64959 & 65032 receive FDA 510(k) clearance?

ULTRAZYME PLUS-GT, #64959 & 65032 received FDA 510(k) clearance on 1982-06-02, under 510(k) number K821468.

Who is the listed applicant for ULTRAZYME PLUS-GT, #64959 & 65032?

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-GT, #64959 & 65032?

The FDA product code for ULTRAZYME PLUS-GT, #64959 & 65032 is JPZ.

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Other records listing Emd Chemicals, 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

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Related Devices (Code: JPZ)

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.

K020486CARESIDE GGTCareside, Inc.K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREData Medical Associates, Inc.K923509GAMMA-GTRandox Laboratories, Ltd.K923091KING DIAGNOSTICS GAMMA GT REAGENTKing Diagnostics, Inc.K905618GGT REAGENTAmresco, Inc.K903304ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, 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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