SENTECH'S ULAB 1000 CLINICAL CHEM.

SENTECH'S ULAB 1000 CLINICAL CHEM. is an FDA 510(k)-cleared medical device (K841575) manufactured by Sen Tech Medical Corp.. 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 July 5, 1984. Regulation: 8.