510(k) K100817

BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST by Princeton BioMeditech Corp. — Product Code KHE

K100817 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST". The FDA issued a decision of Substantially Equivalent on July 1, 2010. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.