ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651— 510(k) K884549

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K884549 for ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651, Substantially Equivalent on 1988-11-10. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 1988-10-31
Decision date: 1988-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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