FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2— 510(k) K210623
Substantially EquivalentSebia
FDA 510(k) clearance K210623 for FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2, Substantially Equivalent on 2022-11-18. Applicant: Sebia. Device class: 2.
Clearance details
- Applicant
- Sebia
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
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More clearances from Sebia
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