HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE is an FDA 510(k)-cleared medical device (K041728) manufactured by Immunostics 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 August 10, 2004. Regulation: 8.