SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422— 510(k) K903335

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K903335 for SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422, Substantially Equivalent on 1990-08-17. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDO
Advisory panel: Clinical Chemistry
Date received: 1990-07-25
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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