COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR is an FDA 510(k)-cleared medical device (K141928) manufactured by Roche Diagnostics Operations (Rdo). This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 2014. Regulation: 8.