Roche Diagnostics Operations (Rdo)
Tina-quant Hemoglobin A1cDx Gen.3
SKU K193053UPC PDJ
In Stock
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IIFDA 510(k) Cleared (K193053)
1
Free shipping on orders over $99 · 30-day returns
Roche Diagnostics Operations (Rdo)
Free shipping on orders over $99 · 30-day returns
Tina-quant Hemoglobin A1cDx Gen.3 is an FDA 510(k)-cleared medical device (K193053) 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 March 25, 2020. Regulation: 8.
