DURAZYME CPK— 510(k) K821452

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K821452 for DURAZYME CPK, Substantially Equivalent on 1982-05-28. Applicant: American Monitor Corp..

Clearance details

Applicant: American Monitor Corp.
Advisory panel: Unknown
Date received: 1982-05-14
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.