510(k) K140446

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY by Becton, Dickinson & CO — Product Code MKZ

K140446 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY". The FDA issued a decision of Substantially Equivalent on May 20, 2014. The device falls under product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia), a Class I device regulated under 21 CFR 866.3120. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.