Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Sebia with 34 510(k) clearances. The most recent is a 510(k) clearance dated Apr 4, 2024: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 4, 2024 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentK232027 · GKA | 510(k) clearances |
| Feb 23, 2024 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2K231601 · DFH | 510(k) clearances |
| Nov 18, 2022 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2K210623 · DFH | 510(k) clearances |
| Nov 12, 2021 | HYDRASHIFT 2/4 isatuximabK203184 · CFF | 510(k) clearances |
| Nov 1, 2019 | CAPI 3 Immunotyping, Capillarys 3 TeraK192095 · CFF | 510(k) clearances |
| May 2, 2019 | HYDRASHIFT 2/4 daratumumabK190851 · CFF | 510(k) clearances |
| Dec 14, 2018 | CAPI 3 HEMOGLOBIN(E)K180762 · GKA | 510(k) clearances |
| Feb 7, 2018 | CAPILLARYS Hb A1cK171861 · PDJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
