510(k) K882325

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST by Sclavo, Inc. — Product Code GFO

K882325 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST". The FDA issued a decision of Substantially Equivalent on August 25, 1988. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Sclavo, Inc. has at least 10 other 510(k) clearances on record.