510(k) K865000

IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS by Sclavo, Inc. — Product Code LET

K865000 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code LET (Fluorescent Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Sclavo, Inc. has at least 10 other 510(k) clearances on record.