FDA 510(k) Applications for Medical Device Product Code "LSL"
(Dna-Reagents, Neisseria)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K935833 | ABBOTT LABORATORIES | LCX NEISSERIA GONORRHOEAE ASSAY | 05/06/1996 |
| K140354 | ABBOTT MOLECULAR, INC. | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | 05/09/2014 |
| K012351 | BECTON DICKINSON & CO. | BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY | 09/18/2001 |
| K984631 | BECTON DICKINSON MICROBIOLOGY SYSTEMS | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY | 11/04/1999 |
| K052224 | BECTON, DICKINSON & CO. | BD PROBE TEC URINE PRESERVATIVE TRANSPORT | 09/12/2005 |
| K081825 | BECTON, DICKINSON & CO. | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | 12/11/2008 |
| K090827 | BECTON, DICKINSON & CO. | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | 05/27/2009 |
| K090971 | BECTON, DICKINSON & CO. | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | 06/05/2009 |
| K091730 | BECTON, DICKINSON & CO. | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | 11/13/2009 |
| K140448 | BECTON, DICKINSON & CO. | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | 05/20/2014 |
| K052481 | BECTON, DICKINSON & CO. | BD VIPER SYSTEM | 11/28/2005 |
| K121710 | CEPHEID | XPERT CT/NG | 12/27/2012 |
| K173840 | Cepheid | Xpert CT/NG | 03/16/2018 |
| K981567 | DIGENE CORP. | HYBRID CAPTURE II CT/GC TEST | 02/29/2000 |
| K981485 | DIGENE CORP. | HYBRID CAPTURE II GC-ID | 11/29/1999 |
| K010893 | DIGENE CORP. | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 | 09/24/2001 |
| K111409 | GEN-PROBE, INC. | APTIMA COMBO 2 ASSAY | 05/03/2012 |
| K043144 | GEN-PROBE, INC. | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE | 03/14/2005 |
| K063664 | GEN-PROBE, INC. | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | 01/25/2007 |
| K062440 | GEN-PROBE, INC. | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | 11/07/2006 |
| K003395 | GEN-PROBE, INC. | GEN-PROBE APTIMA COMBO 2 ASSAY | 05/21/2001 |
| K032554 | GEN-PROBE, INC. | GEN-PROBE APTIMA COMBO 2 ASSAY | 12/31/2003 |
| K043224 | GEN-PROBE, INC. | GEN-PROBE APTIMA COMBO 2 ASSAY | 08/09/2005 |
| K032194 | GEN-PROBE, INC. | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS | 12/24/2003 |
| K061509 | GEN-PROBE, INC. | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | 10/04/2006 |
| K060652 | GEN-PROBE, INC. | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | 08/17/2006 |
| K132251 | HOLOGIC / GEN-PROBE INCORPORATED | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) | 10/17/2013 |
| K180681 | Hologic, Inc. | Aptima Combo 2 Assay (Panther System) | 06/13/2018 |
| K053289 | ROCHE DIAGNOSTICS CORP. | COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | 08/10/2006 |
| K070172 | ROCHE DIAGNOSTICS CORPORATION | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | 04/17/2007 |
| K173887 | Roche Molecular Systems, Inc. | cobas CT/NG for use on cobas 6800/8800 systems | 03/21/2018 |
| K132270 | ROCHE MOLECULAR SYSTEMS, INC. | COBAS CT/NG V2.0 TEST | 12/02/2013 |
| K140887 | ROCHE MOLECULAR SYSTEMS, INC. | COBAS CT/NG V2.0 TEST | 05/05/2014 |
| K163184 | Roche Molecular Systems, Inc. | cobas« CT/NG v2.0 Test | 02/09/2017 |
| K974503 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | 12/01/1999 |
| K974342 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | 05/28/1999 |
| K991268 | SIERRA DIAGNOSTICS | GONOSTAT GONOCOCCAL DETECTION KIT | 08/11/1999 |
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