VICTORCH MEDITEK'S HCG TEST CARD

VICTORCH MEDITEK'S HCG TEST CARD is an FDA 510(k)-cleared medical device (K013678) manufactured by Victorch Meditek, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2001. Regulation: 8.