
Roche Diagnostics Operations
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COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY is an FDA 510(k)-cleared medical device (K121610) manufactured by Roche Diagnostics Operations. 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 August 7, 2013. Regulation: 8.