LSL — Dna-Reagents, Neisseria Class II
FDA product code LSL covers "Dna-Reagents, Neisseria", a Class II medical device regulated under 21 CFR 866.3390. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LSL
- Device Class
- Class II
- Regulation Number
- 866.3390
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231329 | hologic | Aptima Neisseria gonorrhoeae Assay | January 26, 2024 |
| K180681 | hologic | Aptima Combo 2 Assay (Panther System) | June 13, 2018 |
| K173887 | roche molecular systems | cobas CT/NG for use on cobas 6800/8800 systems | March 21, 2018 |
| K173840 | cepheid | Xpert CT/NG | March 16, 2018 |
| K163184 | roche molecular systems | cobas® CT/NG v2.0 Test | February 9, 2017 |
| K140448 | becton, dickinson and | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | May 20, 2014 |
| K140354 | abbott molecular | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | May 9, 2014 |
| K140887 | roche molecular systems | COBAS CT/NG V2.0 TEST | May 5, 2014 |
| K132270 | roche molecular systems | COBAS CT/NG V2.0 TEST | December 2, 2013 |
| K132251 | hologic / gen-probe incorporated | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) | October 17, 2013 |
| K121710 | cepheid | XPERT CT/NG | December 27, 2012 |
| K111409 | gen-probe | APTIMA COMBO 2 ASSAY | May 3, 2012 |
| K091730 | becton, dickinson and | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | November 13, 2009 |
| K090971 | becton, dickinson and | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | June 5, 2009 |
| K090827 | becton, dickinson and | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY | May 27, 2009 |
| K081825 | becton, dickinson and | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | December 11, 2008 |
| K070172 | roche diagnostics corporation | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | April 17, 2007 |
| K063664 | gen-probe | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | January 25, 2007 |
| K062440 | gen-probe | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | November 7, 2006 |
| K061509 | gen-probe | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 | October 4, 2006 |