
Sigma Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
FIBRINOGEN DETERMINATION KIT is an FDA 510(k)-cleared medical device (K913061) manufactured by Sigma Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 8, 1991. Regulation: 8.