FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
FDA 510(k) clearance K231601 · decided 2024-02-23
Clearance details
- K-number
- K231601
- Device name
- FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2023-06-01
- Decision date
- 2024-02-23
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- DFH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.