510(k) K121397

OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT by SEKISUI Diagnostics, LLC — Product Code KHE

K121397 is an FDA 510(k) premarket notification submitted by SEKISUI Diagnostics, LLC for the device "OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT". The FDA issued a decision of Substantially Equivalent on December 28, 2012. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. SEKISUI Diagnostics, LLC has at least 5 other 510(k) clearances on record.