EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay— 510(k) K182353
Substantially EquivalentPhadia AB
FDA 510(k) clearance K182353 for EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay, Substantially Equivalent on 2018-11-27. Applicant: Phadia AB. Device class: 2.
Clearance details
- Applicant
- Phadia AB
- Product code
- Code LJM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code LJM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.