S-TEST C02— 510(k) K073223

Substantially Equivalent

Alfa Wassermann Diagnostic Technologies, Inc.

FDA 510(k) clearance K073223 for S-TEST C02, Substantially Equivalent on 2008-06-26. Applicant: Alfa Wassermann Diagnostic Technologies, Inc..

Clearance details

Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
Product code: Code KHS
Advisory panel: Clinical Chemistry
Date received: 2007-11-15
Decision date: 2008-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

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