510(k) K163554

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test by Immunostics Inc., — Product Code KHE

K163554 is an FDA 510(k) premarket notification submitted by Immunostics Inc., for the device "hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test". The FDA issued a decision of Substantially Equivalent on January 17, 2017. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Immunostics Inc., has at least 10 other 510(k) clearances on record.