Sebia: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Sebia” (first 1995, latest 2024), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 230 days, against 218 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 267 |
| 2013 | 1 | 150 |
| 2014 | 1 | 149 |
| 2015 | 1 | 31 |
| 2016 | 1 | 160 |
| 2017 | 2 | 148 |
| 2018 | 3 | 230 |
| 2019 | 2 | 59 |
| 2020 | 0 | — |
| 2021 | 1 | 381 |
| 2022 | 1 | 626 |
| 2023 | 0 | — |
| 2024 | 2 | 270 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sebia took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 218 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 8 | 8 |
| GKA | Abnormal Hemoglobin Quantitation | 7 | 7 |
| DFH | Kappa, Antigen, Antiserum, Control | 3 | 3 |
| LCP | Assay, Glycosylated Hemoglobin | 3 | 3 |
| CEF | Electrophoretic, Protein Fractionation | 2 | 2 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| JKM | Immunochemical, Bence-Jones Protein | 2 | 2 |
| PDJ | Hemoglobin A1c Test System | 2 | 2 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 | 1 |
Plus 2 more product codes.
Review panels
- Immunology (14)
- Clinical Chemistry (10)
- Hematology (10)
Most recent Sebia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | GKA | 2024-04-04 | 272 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | DFH | 2024-02-23 | 267 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | DFH | 2022-11-18 | 626 |
| K203184 | HYDRASHIFT 2/4 isatuximab | CFF | 2021-11-12 | 381 |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | CFF | 2019-11-01 | 88 |
| K190851 | HYDRASHIFT 2/4 daratumumab | CFF | 2019-05-02 | 30 |
| K180762 | CAPI 3 HEMOGLOBIN(E) | GKA | 2018-12-14 | 266 |
| K171861 | CAPILLARYS Hb A1c | PDJ | 2018-02-07 | 230 |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | CFF | 2018-01-11 | 174 |
| K171537 | CAPI 3 Hb A1c | PDJ | 2017-09-12 | 110 |
24 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-08-29.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sebia?
FDA lists 34 510(k) clearances under the applicant name “Sebia” (first 1995, latest 2024), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sebia?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sebia is 206 days. Since 2017: 230 days, versus 218 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sebia?
The most frequent FDA product codes under this applicant name are CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M), 8); GKA (Abnormal Hemoglobin Quantitation, 7); DFH (Kappa, Antigen, Antiserum, Control, 3).
Next steps
- See all 34 Sebia clearances with predicates and recalls
- Run predicate analysis for product code CFF, Sebia's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.