
Alfa Wassermann Diagnostic Technologies, Inc.
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S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU is an FDA 510(k)-cleared medical device (K072140) manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2008. Regulation: 8.