510(k) Report

Devices descending from K984631

14 later devices reach Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081824BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO20089—
+1K052481BD Viper SystemBecton, Dickinson & CO20050—
+1K052224BD Probe Tec Urine Preservative TransportBecton, Dickinson & CO20051—
+1K023955BD Viper InstrumentBecton, Dickinson & CO20031—
+2K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company201662
+2K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO20140—
+2K090824BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO20090—
+2K080739Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc.20080—
+3K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+3K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company20193—
+4K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+4K210585BD CTGCTV2Becton, Dickinson and Company202211
+4K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc.20210—
+5K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—