TITAN GEL ALKALINE PHOSPHATASE (HR)

TITAN GEL ALKALINE PHOSPHATASE (HR) is an FDA 510(k)-cleared medical device (K921578) manufactured by Helena Laboratories. 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 September 22, 1992. Regulation: 8.