DBEST REAGENT STRIP FOR URINALYSIS

DBEST REAGENT STRIP FOR URINALYSIS is an FDA 510(k)-cleared medical device (K973142) manufactured by Ameritek, 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 October 19, 1997. Regulation: 8.