Phadia AB: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Phadia AB” (first 2007, latest 2026), across 15 product codes in 1 review panel. Median 510(k) review time under this name: 232 days. Since 2017 the median was 132 days, against 214 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.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 252 |
| 2014 | 1 | 110 |
| 2015 | 1 | 258 |
| 2016 | 4 | 272 |
| 2017 | 1 | 155 |
| 2018 | 8 | 84 |
| 2019 | 3 | 232 |
| 2020 | 1 | 87 |
| 2021 | 3 | 376 |
| 2022 | 2 | 437 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Phadia AB took a median 132 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 16 | 16 |
| DGC | Ige, Antigen, Antiserum, Control | 2 | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 | 2 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 1 | 1 |
Plus 5 more product codes.
Review panels
- Immunology (33)
Most recent Phadia AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253367 | EliA CTD 13 Screen | LLL | 2026-06-25 | 268 |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed | DHB | 2022-08-03 | 386 |
| K210902 | EliA Ro52, EliA Ro60 | LKJ | 2022-07-27 | 488 |
| K202541 | EliA RNA Pol III | NYO | 2021-09-13 | 376 |
| K202540 | EliA Rib-P | MQA | 2021-09-13 | 376 |
| K202067 | EliA SmDP-S | LKP | 2021-07-14 | 352 |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | DHB | 2020-05-01 | 87 |
| K190710 | EliA SymphonyS Immunoassay | LLL | 2019-11-29 | 255 |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | DHB | 2019-05-14 | 90 |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | MVM | 2019-03-01 | 232 |
23 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2023-05-24.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Phadia US, Inc. (21 510(k)s)
- Phadia GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Phadia AB?
FDA lists 33 510(k) clearances under the applicant name “Phadia AB” (first 2007, latest 2026), across 15 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Phadia AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phadia AB is 232 days. Since 2017: 132 days, versus 214 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Phadia AB?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 16); DGC (Ige, Antigen, Antiserum, Control, 2); LKP (Anti-Sm Antibody, Antigen And Control, 2).
Next steps
- See all 33 Phadia AB clearances with predicates and recalls
- Run predicate analysis for product code DHB, Phadia AB'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.