510(k) K902543

ACID PHOSPHOTASE REAGENT TEST AND KIT by Crestat Diagnostics, Inc. — Product Code CKB

K902543 is an FDA 510(k) premarket notification submitted by Crestat Diagnostics, Inc. for the device "ACID PHOSPHOTASE REAGENT TEST AND KIT". The FDA issued a decision of Substantially Equivalent on September 7, 1990. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Crestat Diagnostics, Inc. has at least 10 other 510(k) clearances on record.