510(k) K905396

HEMASTIX REAGENT STRIPS by Heraeus Kulzer, Inc. — Product Code JIO

K905396 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "HEMASTIX REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.