510(k) K860773

TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 by Clinical Sciences, Inc. — Product Code LGD

K860773 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.