Data / Medical devices / Sweden / Phadia AB
Phadia AB: FDA-registered device maker in Uppsala, Sweden, 24 510(k) clearances
Phadia AB is registered with the FDA (registration 3039353646) in Uppsala, Sweden. It lists 19 device types. The FDA files 24 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039353646
- Address
- Almungevagen 35, Uppsala, Sweden, 754 54
- Owner or operator
- PHADIA AB (9004441)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 11, 2006
- Registered through
- 2026
- Brand names listed
- Development Solution, Dilution Plate, Phadia 250, Dilution Well, EliA ANA 3 Positive Control 250, EliA ANA 3 Positive Control 2500/5000, EliA ANA Positive Control 250, EliA ANA Positive Control 2500/5000, EliA ANCA/GBM Positive Control 2500/5000 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | K253367 | EliA CTD 13 Screen | LLL | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| August 3, 2022 | 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 | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| May 1, 2020 | K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| May 14, 2019 | 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 | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| May 5, 2017 | K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| March 25, 2016 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | JZO | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| February 29, 2016 | K150597 | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| December 14, 2015 | K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| October 27, 2014 | K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | MOB | Substantially Equivalent | Phadia US, Inc. | accessdata.fda.gov |
| August 28, 2013 | K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | DHB | Substantially Equivalent | Phadia US, Inc. | accessdata.fda.gov |
| July 10, 2013 | K131738 | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| June 28, 2013 | K123275 | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| March 13, 2013 | K121156 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| January 29, 2013 | K121463 | IMMUNOCAP ALLERGEN K82 | DHB | Substantially Equivalent | Thermo Fisher Scientific | accessdata.fda.gov |
| September 13, 2012 | K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | DHB | Substantially Equivalent | Phadia US, Inc. | accessdata.fda.gov |
| December 22, 2011 | K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | DHB | Substantially Equivalent | Phadia US, Inc. | accessdata.fda.gov |
| May 27, 2011 | K101251 | IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| December 15, 2010 | K100999 | IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| June 7, 2010 | K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | MID | Substantially Equivalent | Phadia US, Inc. | accessdata.fda.gov |
| November 20, 2009 | K092050 | IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| December 7, 2007 | K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | LSW | Substantially Equivalent | Phadia US, Inc. | accessdata.fda.gov |
| August 24, 2007 | K071913 | IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 | DHB | Substantially Equivalent | Phadia AB | accessdata.fda.gov |
| August 3, 2006 | K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 | NHX | Substantially Equivalent | Sweden Diagnostics (Us), Inc. | accessdata.fda.gov |
| June 9, 2005 | K051218 | MODIFICATION TO: UNICAP SPECIFIC IGE | DHB | Substantially Equivalent | Pharmacia Diagnostics AB | accessdata.fda.gov |
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Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.