
Princeton BioMeditech Corp.
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LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG is an FDA 510(k)-cleared medical device (K945514) 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 9, 1995. Regulation: 8.