BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT

BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT is an FDA 510(k)-cleared medical device (K934293) manufactured by Beckman-Diagnostic Systems Group. 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 5, 1994. Regulation: 8.