EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay— 510(k) K181329
Substantially EquivalentPhadia AB
FDA 510(k) clearance K181329 for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay, Substantially Equivalent on 2018-06-25. Applicant: Phadia AB. Device class: 2.
Clearance details
- Applicant
- Phadia AB
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
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- K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.