COMP. CLIN. CHEM. REF. SERUM-BENCHMARK

COMP. CLIN. CHEM. REF. SERUM-BENCHMARK is an FDA 510(k)-cleared medical device (K780553) manufactured by Beckman Instruments, Inc.. 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 18, 1978. Regulation: 8.