Roche Diagnostics
ONLINE TDM Phenytoin - Free Phenytoin application
SKU K230161UPC MOJ
In Stock
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IIFDA 510(k) Cleared (K230161)
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Free shipping on orders over $99 · 30-day returns
Roche Diagnostics
Free shipping on orders over $99 · 30-day returns
ONLINE TDM Phenytoin - Free Phenytoin application is an FDA 510(k)-cleared medical device (K230161) manufactured by Roche Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2023. Regulation: 8.
