
Roche Diagnostics
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C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C is an FDA 510(k)-cleared medical device (K052101) manufactured by Roche Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 2005. Regulation: 8.