OPTI Medical Systems, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 3
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2310-2021 | Class II | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 | June 25, 2021 |
| Z-0029-2014 | Class II | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes ar | August 9, 2013 |
| Z-2440-2012 | Class II | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS | July 3, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200986 | OPTI® B-Lac Cassette | August 2, 2021 |
| K131126 | OPTI CCA-TS2 | August 22, 2013 |
| K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | January 7, 2011 |