
Princeton BioMeditech Corp.
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BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB is an FDA 510(k)-cleared medical device (K961024) manufactured by Princeton BioMeditech Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 1997. Regulation: 8.