510(k) K090971

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY by Becton, Dickinson & CO — Product Code LSL

K090971 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY". The FDA issued a decision of Substantially Equivalent on June 5, 2009. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.