S-TEST C02— 510(k) K073223

Clearance details

Applicant

Alfa Wassermann Diagnostic Technologies, Inc.

Product code

Code KHS

Device class

Class 2

Regulation

21 CFR 862.1160

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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