K821452Substantially Equivalent

Durazyme Cpk

Name: K821452 Durazyme Cpk
Creator: American Monitor Corp.
Published: 1982-05-28
License: https://open.fda.gov/license/

American Monitor Corp., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K821452 is the FDA 510(k) clearance record for DURAZYME CPK, cleared for American Monitor Corp. on 1982-05-28. FDA records list 73 510(k) clearances for American Monitor Corp., from 1977-02-22 to 1990-01-11. As of 2026-09-10, FDA records show no recalls naming K821452.

Clearance record

Decision date: 1982-05-28
Received: 1982-05-14 (14 days to decision)
Review panel: Unknown
Applicant: American Monitor Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No