Streck
FDA 510(k) & PMA Approved Devices — 28 products
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Total Devices28
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254166 | MDx-Chex for BCN | PMN | 2026-03-23 | View |
| 510(k) | K231223 | MDx-Chex for BC-GN | PMN | 2023-07-27 | View |
| 510(k) | K231221 | MDx-Chex for BC-GP | PMN | 2023-07-27 | View |
| 510(k) | K170091 | UA-Cellular Complete | JJW | 2017-02-09 | View |
| 510(k) | K160588 | XN CHECK BF | JPK | 2016-12-22 | View |
| 510(k) | K160590 | XN CHECK | JPK | 2016-12-22 | View |
| 510(k) | K160585 | XN CAL | KRX | 2016-12-22 | View |
| 510(k) | K160586 | XN-L CHECK | JPK | 2016-12-22 | View |
| 510(k) | K120747 | XN CAL PF | KRX | 2012-10-22 | View |
| 510(k) | K120742 | XN CHECK | JPK | 2012-10-19 | View |
| 510(k) | K120745 | XN CAL | KRX | 2012-10-19 | View |
| 510(k) | K120744 | XN CHECK BF | JPK | 2012-10-19 | View |
| 510(k) | K111211 | CELL-DYN 22 PLUS CONTROL | GLQ | 2011-12-22 | View |
| 510(k) | K111204 | CELL-DYN 22 PLUS CALIBRATOR | KRX | 2011-12-22 | View |
| 510(k) | K110718 | CELL-CHEX WITH CPPD CRYSTALS | GLQ | 2011-05-26 | View |
| 510(k) | K101335 | CELL-CHEX | GLQ | 2010-08-23 | View |
| 510(k) | K090201 | UA-CELLULAR FOR IQ | JPK | 2009-03-27 | View |
| 510(k) | K090137 | STAK-CHEX PLUS RETICS | GLQ | 2009-03-18 | View |
| 510(k) | K083926 | CD4 COUNT | GGL | 2009-02-11 | View |
| 510(k) | K083200 | X-CAL | KRX | 2009-02-03 | View |
No matching devices.
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