EliA SymphonyS Immunoassay
FDA 510(k) clearance K190710 · decided 2019-11-29
Clearance details
- K-number
- K190710
- Device name
- EliA SymphonyS Immunoassay
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2019-03-19
- Decision date
- 2019-11-29
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.