EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
FDA 510(k) clearance K173792 · decided 2018-03-13
Clearance details
- K-number
- K173792
- Device name
- EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2017-12-14
- Decision date
- 2018-03-13
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- MOB
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnos recall (Z-0783-2024) | Phadia Ab | 2024-01-24 |