Sebia
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories5
Latest Approval2024-04-04
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | GKA | 2024-04-04 | View |
| 510(k) | K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | DFH | 2024-02-23 | View |
| 510(k) | K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | DFH | 2022-11-18 | View |
| 510(k) | K203184 | HYDRASHIFT 2/4 isatuximab | CFF | 2021-11-12 | View |
| 510(k) | K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | CFF | 2019-11-01 | View |
| 510(k) | K190851 | HYDRASHIFT 2/4 daratumumab | CFF | 2019-05-02 | View |
| 510(k) | K180762 | CAPI 3 HEMOGLOBIN(E) | GKA | 2018-12-14 | View |
| 510(k) | K171861 | CAPILLARYS Hb A1c | PDJ | 2018-02-07 | View |
| 510(k) | K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | CFF | 2018-01-11 | View |
| 510(k) | K171537 | CAPI 3 Hb A1c | PDJ | 2017-09-12 | View |
| 510(k) | K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | LCP | 2017-02-17 | View |
| 510(k) | K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | CFF | 2016-12-21 | View |
No matching devices.