STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715

STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 is an FDA 510(k)-cleared medical device (K870746) manufactured by Stanbio Laboratory. 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 May 31, 1987. Regulation: 8.