UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM— 510(k) K852481

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K852481 for UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM, Substantially Equivalent on 1985-08-21. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JJQ
Advisory panel: Clinical Chemistry
Date received: 1985-06-11
Decision date: 1985-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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