ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT is an FDA 510(k)-cleared medical device (K955266) manufactured by Boehringer Mannheim Italia Spa. 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 February 28, 1996. Regulation: 8.