Cleared Traditional

FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

K210623 · Sebia · Immunology
Nov 2022
Decision
626d
Days
Class 2
Risk

About This 510(k) Submission

K210623 is an FDA 510(k) clearance for the FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 18, 2022, 626 days after receiving the submission on March 2, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K210623 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2021
Decision Date November 18, 2022
Days to Decision 626 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DFH — Kappa, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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