Roche Diagnostics Operations (Rdo)
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
SKU K160571UPC PDJ
In Stock
—
IIFDA 510(k) Cleared (K160571)
1
Free shipping on orders over $99 · 30-day returns
Roche Diagnostics Operations (Rdo)
Free shipping on orders over $99 · 30-day returns
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is an FDA 510(k)-cleared medical device (K160571) manufactured by Roche Diagnostics Operations (Rdo). 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 December 18, 2016. Regulation: 8.
