
Princeton BioMeditech Corp.
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CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN is an FDA 510(k)-cleared medical device (K952360) 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 August 13, 1995. Regulation: 8.