DeviceClearance

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2— 510(k) K231601

Substantially Equivalent

Sebia

FDA 510(k) clearance K231601 for FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2, Substantially Equivalent on 2024-02-23. Applicant: Sebia.

Clearance details

Applicant
Sebia
Product code
Code DFH
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norcross, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.