Company ยท SE
Phadia AB
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (1 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 18 |
| LKP | Anti-Sm Antibody, Antigen And Control | 3 |
| DGC | Ige, Antigen, Antiserum, Control | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| MQA | Anti-Ribosomal P Antibodies | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 1 |
| NYO | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody | 1 |
| OYL | Tryptase Assay System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2026 | K253367 | EliA CTD 13 Screen Phadia AB, SE | LLL |
| Aug 3, 2022 | K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Phadia AB, SE | DHB |
| Jul 27, 2022 | K210902 | EliA Ro52, EliA Ro60 Phadia AB, SE | LKJ |
| Sep 13, 2021 | K202541 | EliA RNA Pol III Phadia AB, SE | NYO |
| Sep 13, 2021 | K202540 | EliA Rib-P Phadia AB, SE | MQA |
| Jul 14, 2021 | K202067 | EliA SmDP-S Phadia AB, SE | LKP |
| May 1, 2020 | K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine Phadia AB, SE | DHB |
| Nov 29, 2019 | K190710 | EliA SymphonyS Immunoassay Phadia AB, SE | LLL |
| May 14, 2019 | K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, Immu Phadia AB, SE | DHB |
| Mar 1, 2019 | K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay Phadia AB, SE | MVM |
| Dec 24, 2018 | K183007 | EliA SmDP Immunoassay Phadia AB, SE | LKP |
| Dec 18, 2018 | K182747 | EliA RF IgM Immunoassay Phadia AB, SE | DHR |
| Nov 27, 2018 | K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay Phadia AB, SE | LJM |
| Jul 13, 2018 | K181556 | EliA M2 Immunoassay Phadia AB, SE | DBM |
| Jun 25, 2018 | K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB, SE | MSV |
| Apr 16, 2018 | K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut Phadia AB, SE | DHB |
| Mar 13, 2018 | K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay Phadia AB, SE | MOB |
| Mar 2, 2018 | K173704 | ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, I Phadia AB, SE | OYL |
| May 5, 2017 | K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE Phadia AB, SE | DHB |
| Jul 28, 2016 | K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Cont Phadia AB, SE | DGC |
| Mar 25, 2016 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 25 Phadia AB, SE | JZO |
| Feb 29, 2016 | K150597 | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite Phadia AB, SE | DHB |
| Jan 19, 2016 | K151029 | Phadia Prime Phadia AB, SE | DHB |
| Dec 14, 2015 | K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, W Phadia AB, SE | DHB |
| Oct 30, 2014 | K140493 | ELIA SCL-70S IMMUNOASSAY Phadia GmbH | LJM |
| Feb 24, 2014 | K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH Phadia AB | DGC |
| Jul 10, 2013 | K131738 | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H Phadia AB, SE | DHB |
| Jun 28, 2013 | K123275 | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM Phadia AB | DHB |
| Mar 13, 2013 | K121156 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES Phadia AB | DHB |
| May 27, 2011 | K101251 | IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN Phadia AB | DHB |
| Dec 15, 2010 | K100999 | IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 Phadia AB | DHB |
| Nov 20, 2009 | K092050 | IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 Phadia AB | DHB |
| Mar 16, 2009 | K081830 | IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 Phadia AB | DHB |
| Aug 24, 2007 | K071913 | IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 Phadia AB, SE | DHB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2024 | Phadia Ab EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic Open, Classified |
MOB | K140225 K173792 |
| Jul 9, 2019 | Phadia Ab Phadia" 1000
Model # 12-3800-01
Product Usage:
The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all st Terminated |
DHB | K051218 |
| May 10, 2019 | Phadia Ab EliA RF IgM Well, REF 14-5600-01
Product Usage: Usage:
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-hepar Terminated |
DHR | K102673 K182747 |
| Nov 20, 2017 | Phadia Ab Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version Terminated |
DHB | K151029 |
| Jan 28, 2016 | Phadia Ab EliA SmDP Well, Article Number 14-5624-01
Product Usage:
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate Terminated |
LKP | K132631 |