FDA 510(k)

DURAZYME CPK

K-Number: K821452 · 1982-05-28

Decision Date1982-05-28

Product Code

DecisionSubstantially Equivalent

Device Summary

DURAZYME CPK is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1982-05-28 under 510(k) number K821452. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAZYME CPK?

DURAZYME CPK is a medical device that received FDA 510(k) clearance on 1982-05-28. The listed applicant is American Monitor Corp.. The 510(k) number is K821452.

When did DURAZYME CPK receive FDA 510(k) clearance?

DURAZYME CPK received FDA 510(k) clearance on 1982-05-28, under 510(k) number K821452.

Who is the listed applicant for DURAZYME CPK?

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

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Other records listing American Monitor Corp. as applicant

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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.