
Pathwork Diagnostics
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PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE is an FDA 510(k)-cleared medical device (K092967) manufactured by Pathwork 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 June 7, 2010. Regulation: 8.