PANCREATIC A-AMYLASE EPS

PANCREATIC A-AMYLASE EPS is an FDA 510(k)-cleared medical device (K895880) manufactured by Boehringer Mannheim 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 December 18, 1989. Regulation: 8.