510(k) K991299

MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI by Princeton BioMeditech Corp. — Product Code JHT

K991299 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI". The FDA issued a decision of Substantially Equivalent on May 28, 1999. The device falls under product code JHT (Chromatographic Separation, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.