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

Kappa, Antigen, Antiserum, Control

Sebia

The following data is part of a premarket notification filed by Sebia with the FDA for Flc Kappa, Flc Lambda, Flc Control Level 1, Flc Control Level 2.

Pre-market Notification Details

Device IDK210623
510k NumberK210623
Device Name:FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
ClassificationKappa, Antigen, Antiserum, Control
Applicant Sebia 1705 Corporate Drive Suite 400 Norcross,  GA  30093
ContactKaren Anderson
CorrespondentKaren Anderson
Sebia 1705 Corporate Drive Suite 400 Norcross,  GA  30093
Product CodeDFH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-02
Decision Date2022-11-18

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