DURAZYME(R) CPK— 510(k) K883504

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K883504 for DURAZYME(R) CPK, Substantially Equivalent on 1988-09-13. Applicant: American Monitor Corp..

Clearance details

Applicant: American Monitor Corp.
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1988-08-17
Decision date: 1988-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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