510(k) K173212

Instant-view-PLUS immunochemical Fecal Occult Blood Test by Alfa Scientific Designs, Inc. — Product Code KHE

K173212 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "Instant-view-PLUS immunochemical Fecal Occult Blood Test". The FDA issued a decision of Substantially Equivalent on February 15, 2018. The device falls under product code KHE (Reagent, Occult Blood), a Class II device regulated under 21 CFR 864.6550. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.