ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST— 510(k) K914068

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K914068 for ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST, Substantially Equivalent on 1991-10-02. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIT
Advisory panel: Clinical Chemistry
Date received: 1991-09-11
Decision date: 1991-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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