DeviceClearance

EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK— 510(k) K861061

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K861061 for EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK, Substantially Equivalent on 1986-04-24. Applicant: Em Diagnostic Systems, Inc..

Clearance details

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