510(k) K860145

RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 by Clinical Sciences, Inc. — Product Code LFX

K860145 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540". The FDA issued a decision of Substantially Equivalent on July 14, 1986. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.