PANCREATIC A-AMYLASE PNP

PANCREATIC A-AMYLASE PNP is an FDA 510(k)-cleared medical device (K892848) 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 July 19, 1989. Regulation: 8.