FDA 510(k) Applications Submitted by Phadia AB
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K212181 |
07/13/2021 |
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 |
Phadia AB |
| K151029 |
04/17/2015 |
Phadia Prime |
PHADIA AB |
| 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 |
| K071913 |
07/11/2007 |
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 |
PHADIA AB |
| K100999 |
04/12/2010 |
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 |
PHADIA AB |
| K121156 |
04/16/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA AB |
| K101251 |
05/04/2010 |
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN |
PHADIA AB |
| K081830 |
06/30/2008 |
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 |
PHADIA AB |
| K092050 |
07/07/2009 |
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 |
PHADIA AB |
| K123275 |
10/19/2012 |
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM |
PHADIA AB |
| K133404 |
11/06/2013 |
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH |
PHADIA AB |
| K210902 |
03/26/2021 |
EliA Ro52, EliA Ro60 |
Phadia AB |
| K202541 |
09/02/2020 |
EliA RNA Pol III |
Phadia AB |
| K190315 |
02/13/2019 |
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 |
Phadia AB |
| K161899 |
07/11/2016 |
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 C |
PHADIA AB |
| K173726 |
12/05/2017 |
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut |
Phadia AB |
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