510(k) K021423

INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST by Alfa Scientific Designs, Inc. — Product Code KHE

K021423 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST". The FDA issued a decision of Substantially Equivalent on June 17, 2002. 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.