P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT

P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT is an FDA 510(k)-cleared medical device (K904761) manufactured by Instrumentation Laboratory CO. 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 November 19, 1990. Regulation: 8.