DURAZYME CPK— 510(k) K833781

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K833781 for DURAZYME CPK, Substantially Equivalent on 1984-01-18. Applicant: American Monitor Corp..

Clearance details

Applicant: American Monitor Corp.
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1983-10-28
Decision date: 1984-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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