FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS

FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS is an FDA 510(k)-cleared medical device (K112101) manufactured by Polymed Therapeutics, 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 July 16, 2012. Regulation: 8.