SYSTE MATE TIBC HEM NO. 67225— 510(k) K850128

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K850128 for SYSTE MATE TIBC HEM NO. 67225, Substantially Equivalent on 1985-02-01. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JMO
Advisory panel: Clinical Chemistry
Date received: 1985-01-14
Decision date: 1985-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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