510(k) K831760

LEGIONELLA IFA KIT I by Bionetic Laboratory Products — Product Code LHL

K831760 is an FDA 510(k) premarket notification submitted by Bionetic Laboratory Products for the device "LEGIONELLA IFA KIT I". The FDA issued a decision of Substantially Equivalent on August 8, 1983. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. Bionetic Laboratory Products has at least 7 other 510(k) clearances on record.