CALIBRATOR, BOVINE SERUM

CALIBRATOR, BOVINE SERUM is an FDA 510(k)-cleared medical device (K781702) manufactured by Bio-Reagents & Diagnostics, 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 November 14, 1978. Regulation: 8.