DeviceClearance

ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17— 510(k) K912807

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K912807 for ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17, Substantially Equivalent on 1991-10-31. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant
Em Diagnostic Systems, Inc.
Product code
Code JFY
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gibbstown, NJ, US
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