EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95— 510(k) K863962

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K863962 for EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95, Substantially Equivalent on 1986-11-28. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CKA
Advisory panel: Clinical Chemistry
Date received: 1986-10-10
Decision date: 1986-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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