LSLClass II
Dna-Reagents, Neisseria
21 CFR 866.3390 / Microbiology
LSL is the FDA product code for Dna-Reagents, Neisseria, a class II device type, regulated under 21 CFR 866.3390. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- LSL
- Device name
- Dna-Reagents, Neisseria
- Regulation
- 21 CFR 866.3390
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 45
- Ingested recalls
- 7
Clearances, product code LSL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1994 | 2 |
| 1996 | 1 |
| 1999 | 5 |
| 2000 | 1 |
| 2001 | 3 |
| 2003 | 2 |
| 2005 | 4 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 3 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 3 |
| 2017 | 1 |
| 2018 | 3 |
| 2024 | 1 |
Applicants with the most clearances
Product code LSL| Applicant | Clearances |
|---|---|
| Hologic, Inc. | 17 |
| Becton Dickinson & Co | 8 |
| Roche Molecular Systems Inc | 6 |
| Qiagen | 3 |
| Cepheid | 2 |
| Roche Diagnostics GmbH | 2 |
| Abbott Medical | 1 |
| Abbott Molecular, Inc. | 1 |
| Becton Dickinson Microbiology Systems | 1 |
| Hologic / Gen-Probe Incorporated | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.