ENZYMATIC ALPHA-AMYLASE REAGENT KIT

ENZYMATIC ALPHA-AMYLASE REAGENT KIT is an FDA 510(k)-cleared medical device (K860245) manufactured by Bio-Analytics Laboratories, 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 March 13, 1986. Regulation: 8.