
Polymed Therapeutics, Inc.
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FASTEP S10 HCG SERUM/URINE COMBO TEST is an FDA 510(k)-cleared medical device (K132834) 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 January 8, 2014. Regulation: 8.