
Biotrol, USA, Inc.
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BIOTROL CREATININE H.P. REAGENT is an FDA 510(k)-cleared medical device (K881856) manufactured by Biotrol, USA, 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 15, 1988. Regulation: 8.