510(k) K984631

BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY by Becton Dickinson Microbiology Systems — Product Code LSL

K984631 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY". The FDA issued a decision of Substantially Equivalent on November 4, 1999. The device falls under product code LSL (Dna-Reagents, Neisseria), a Class II device regulated under 21 CFR 866.3390. Becton Dickinson Microbiology Systems has at least 10 other 510(k) clearances on record.