FDA 510(k) Applications Submitted by Carina Magnusson
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200279 |
02/04/2020 |
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine |
Phadia AB |
| K150597 |
03/09/2015 |
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite |
PHADIA AB |
| K190710 |
03/19/2019 |
EliA SymphonyS Immunoassay |
Phadia AB |
| K150854 |
03/31/2015 |
ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut |
PHADIA AB |
| K181329 |
05/18/2018 |
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay |
Phadia AB |
| K131738 |
06/13/2013 |
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H |
PHADIA AB |
| K181556 |
06/13/2018 |
EliA M2 Immunoassay |
Phadia AB |
| K151799 |
07/02/2015 |
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 |
PHADIA AB |
| K181871 |
07/12/2018 |
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay |
Phadia AB |
| K202067 |
07/27/2020 |
EliA SmDP-S |
Phadia AB |
| K182353 |
08/29/2018 |
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay |
Phadia AB |
| K202540 |
09/02/2020 |
EliA Rib-P |
Phadia AB |
| K182747 |
09/28/2018 |
EliA RF IgM Immunoassay |
Phadia AB |
| K183007 |
10/31/2018 |
EliA SmDP Immunoassay |
Phadia AB |
| K163370 |
12/01/2016 |
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE |
PHADIA AB |
| K173704 |
12/04/2017 |
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip |
Phadia AB |
| K173792 |
12/14/2017 |
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay |
Phadia AB |
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