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Alfa Wassermann Diagnostics Technologies, LLC
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ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT is an FDA 510(k)-cleared medical device (K123322) manufactured by Alfa Wassermann Diagnostics Technologies, LLC. 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 May 20, 2013. Regulation: 8.