MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS

MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS is an FDA 510(k)-cleared medical device (K020662) manufactured by Ortho-Clinical Diagnostics. 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 April 11, 2002. Regulation: 8.