S40 CREATINE KINASE (CK)— 510(k) K082226

Substantially Equivalent

Alfa Wassermann Diagnostic Technologies, Inc.

FDA 510(k) clearance K082226 for S40 CREATINE KINASE (CK), Substantially Equivalent on 2008-09-18. Applicant: Alfa Wassermann Diagnostic Technologies, Inc..

Clearance details

Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
Product code: Code JHS
Advisory panel: Clinical Chemistry
Date received: 2008-08-07
Decision date: 2008-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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