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Alfa Wassermann Diagnostic Technologies, Inc.
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ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT is an FDA 510(k)-cleared medical device (K113389) 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 August 9, 2012. Regulation: 8.