SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205— 510(k) K852483

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K852483 for SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205, Substantially Equivalent on 1985-07-12. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CGS
Advisory panel: Clinical Chemistry
Date received: 1985-06-11
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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