
Gds Technology, LLC
Free shipping on orders over $99 · 30-day returns
HEMOSITE TEST SYSTEM is an FDA 510(k)-cleared medical device (K994073) manufactured by Gds Technology, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 2000. Regulation: 8.