
Princeton BioMeditech Corp.
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BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST is an FDA 510(k)-cleared medical device (K950307) manufactured by Princeton BioMeditech Corp.. 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 February 28, 1995. Regulation: 8.