SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402— 510(k) K895250

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K895250 for SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402, Substantially Equivalent on 1989-10-31. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 1989-08-21
Decision date: 1989-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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