Phadia AB
FDA 510(k) & PMA Approved Dispositivos — 23 products
Publicidade
Total de dispositivos23
Categorias0
Última decisão da FDA
| Tipo | Número | Nome do dispositivo | Código | Data | Ações |
|---|---|---|---|---|---|
| 510(k) | K253367 | EliA CTD 13 Screen | LLL | 2026-06-25 | Ver |
| 510(k) | 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 | Ver |
| 510(k) | K210902 | EliA Ro52, EliA Ro60 | LKJ | 2022-07-27 | Ver |
| 510(k) | K202541 | EliA RNA Pol III | NYO | 2021-09-13 | Ver |
| 510(k) | K202540 | EliA Rib-P | MQA | 2021-09-13 | Ver |
| 510(k) | K202067 | EliA SmDP-S | LKP | 2021-07-14 | Ver |
| 510(k) | K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | DHB | 2020-05-01 | Ver |
| 510(k) | K190710 | EliA SymphonyS Immunoassay | LLL | 2019-11-29 | Ver |
| 510(k) | 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 | Ver |
| 510(k) | K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | MVM | 2019-03-01 | Ver |
| 510(k) | K183007 | EliA SmDP Immunoassay | LKP | 2018-12-24 | Ver |
| 510(k) | K182747 | EliA RF IgM Immunoassay | DHR | 2018-12-18 | Ver |
| 510(k) | K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | LJM | 2018-11-27 | Ver |
| 510(k) | K181556 | EliA M2 Immunoassay | DBM | 2018-07-13 | Ver |
| 510(k) | K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | MSV | 2018-06-25 | Ver |
| 510(k) | K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | DHB | 2018-04-16 | Ver |
| 510(k) | K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | MOB | 2018-03-13 | Ver |
| 510(k) | K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip | OYL | 2018-03-02 | Ver |
| 510(k) | K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | DHB | 2017-05-05 | Ver |
| 510(k) | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | DGC | 2016-07-28 | Ver |
Nenhum dispositivo correspondente.