Roche Diagnostics Operations
cobas HbA1c Test, cobas b 101 system
SKU K163633UPC LCP
In Stock
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IIFDA 510(k) Cleared (K163633)
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Free shipping on orders over $99 · 30-day returns
Roche Diagnostics Operations
Free shipping on orders over $99 · 30-day returns
cobas HbA1c Test, cobas b 101 system is an FDA 510(k)-cleared medical device (K163633) manufactured by Roche Diagnostics Operations. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2017. Regulation: 8.
