EliA SmDP-S
FDA 510(k) clearance K202067 · decided 2021-07-14
Clearance details
- K-number
- K202067
- Device name
- EliA SmDP-S
- Applicant
- Phadia AB
- Decision
- Substantially Equivalent
- Date received
- 2020-07-27
- Decision date
- 2021-07-14
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- LKP
- 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.