FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
EliA M2 Immunoassay
K Number: K181556
·
Decision Jul 13, 2018
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
32
Review Days
30
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Basic Information
- Device Name
- EliA M2 Immunoassay
- K Number
- K181556
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phadia AB
- Date Received
- June 13, 2018
- Decision Date
- July 13, 2018
- Product Code
- DBM
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Phadia AB
| K Number | Device Name | ||
|---|---|---|---|
| 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 | Aug 3, 2022 | Substantially Equivalent |
| K210902 | EliA Ro52, EliA Ro60 | Jul 27, 2022 | Substantially Equivalent |
| K202540 | EliA Rib-P | Sep 13, 2021 | Substantially Equivalent |
| K202541 | EliA RNA Pol III | Sep 13, 2021 | Substantially Equivalent |
| K202067 | EliA SmDP-S | Jul 14, 2021 | Substantially Equivalent |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | May 1, 2020 | Substantially Equivalent |
| K190710 | EliA SymphonyS Immunoassay | Nov 29, 2019 | Substantially Equivalent |
| 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 | May 14, 2019 | Substantially Equivalent |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Mar 1, 2019 | Substantially Equivalent |
| K183007 | EliA SmDP Immunoassay | Dec 24, 2018 | Substantially Equivalent |