
Ortho-Clinical Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III is an FDA 510(k)-cleared medical device (K123930) manufactured by Ortho-Clinical 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 May 14, 2013. Regulation: 8.