Phadia US, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Phadia US, Inc.” (first 2006, latest 2015), plus 1 De Novo decision, across 16 product codes in 1 review panel. Median 510(k) review time under this name: 200 days. 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 | 2 | 282 |
| 2013 | 2 | 293 |
| 2014 | 2 | 322 |
| 2015 | 1 | 262 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 4 | 4 |
| MID | System, Test, Anticardiolipin Immunological | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 | 1 |
Plus 6 more product codes.
Review panels
- Immunology (22)
Most recent Phadia US, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | DBM | 2015-02-13 | 262 |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | MOB | 2014-10-27 | 271 |
| K132631 | EIA SMDP IMMUNOASSAY | LKP | 2014-08-29 | 372 |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | MID | 2013-12-23 | 186 |
| K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | DHB | 2013-08-28 | 400 |
| K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | DHB | 2012-09-13 | 260 |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | MSV | 2012-06-22 | 305 |
| K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | DHB | 2011-12-22 | 168 |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | DHR | 2011-09-30 | 379 |
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 | MST | 2010-08-13 | 280 |
11 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120001 | De Novo | Tryptase Assay System | 2012-02-15 |
Recalls
10 product recalls in 8 recall events; 2 initiated in the last five years. Most recent: 2023-05-01.
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 AB (33 510(k)s)
- Phadia GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Phadia US, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Phadia US, Inc.” (first 2006, latest 2015), plus 1 De Novo decision, across 16 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 US, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phadia US, Inc. is 200 days.
Which FDA product codes appear under Phadia US, Inc.?
The most frequent FDA product codes under this applicant name are DHB (System, Test, Radioallergosorbent (Rast) Immunological, 4); MID (System, Test, Anticardiolipin Immunological, 2); MST (Antibodies, Gliadin, 2).
Next steps
- See all 21 Phadia US, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHB, Phadia US, Inc.'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.