510(k) K022946

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST by Princeton BioMeditech Corp. — Product Code MMI

K022946 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST". The FDA issued a decision of Substantially Equivalent on October 8, 2002. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.