
Chemtron Biotech, Inc.
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CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST is an FDA 510(k)-cleared medical device (K123844) manufactured by Chemtron Biotech, 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 May 29, 2013. Regulation: 8.