Streck
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 38
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1684-2017 | Class II | Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0 | February 23, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260041 | MDx-Chex for BCP | March 27, 2026 |
| K254166 | MDx-Chex for BCN | March 23, 2026 |
| K254167 | MDx-Chex for BCY | March 17, 2026 |
| K231776 | Cell-Free DNA BCT | July 26, 2024 |
| K231221 | MDx-Chex for BC-GP | July 27, 2023 |
| K231223 | MDx-Chex for BC-GN | July 27, 2023 |
| K212576 | MDx-Chex for BCID2 | January 19, 2022 |
| DEN200001 | Cell-Free DNA BCT | August 7, 2020 |
| K170091 | UA-Cellular Complete | February 9, 2017 |
| K160585 | XN CAL | December 22, 2016 |
| K160586 | XN-L CHECK | December 22, 2016 |
| K160590 | XN CHECK | December 22, 2016 |
| K160588 | XN CHECK BF | December 22, 2016 |
| K141957 | XN CHECK BF | December 5, 2014 |
| K141962 | XN CAL | December 5, 2014 |
| K141955 | XN CAL PF | December 5, 2014 |
| K141964 | XN CHECK | December 5, 2014 |
| K131444 | UA-CELLULAR COMPLETE | January 29, 2014 |
| K120747 | XN CAL PF | October 22, 2012 |
| K120744 | XN CHECK BF | October 19, 2012 |