ASPARTATE AMINOTRANSFERASE (AST) TEST— 510(k) K935181

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K935181 for ASPARTATE AMINOTRANSFERASE (AST) TEST, Substantially Equivalent on 1994-01-27. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIT
Advisory panel: Clinical Chemistry
Date received: 1993-10-26
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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