
Bio-Rad Laboratories, Inc.
Free shipping on orders over $99 · 30-day returns
ACCESS CK-MB REAGENTS is an FDA 510(k)-cleared medical device (K945083) manufactured by Bio-Rad Laboratories, 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 20, 1994. Regulation: 8.