510(k) K881204

ACP KINETIC TEST (ACID PHOSPHATASE TEST) by Sclavo, Inc. — Product Code CKB

K881204 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "ACP KINETIC TEST (ACID PHOSPHATASE TEST)". The FDA issued a decision of Substantially Equivalent on April 28, 1988. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Sclavo, Inc. has at least 10 other 510(k) clearances on record.