510(k) K832069

TOXO IPA KIT IAN INDIRECT FLUORESCENT by Bionetic Laboratory Products — Product Code LJK

K832069 is an FDA 510(k) premarket notification submitted by Bionetic Laboratory Products for the device "TOXO IPA KIT IAN INDIRECT FLUORESCENT". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code LJK (Antisera, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Bionetic Laboratory Products has at least 7 other 510(k) clearances on record.