SYSTE MATE IRON, HEM NO. 67224— 510(k) K845020

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K845020 for SYSTE MATE IRON, HEM NO. 67224, Substantially Equivalent on 1985-01-28. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JIY
Advisory panel: Clinical Chemistry
Date received: 1984-12-27
Decision date: 1985-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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