HYDRASHIFT 2/4 Isatuximab

Immunoelectrophoretic, Immunoglobulins, (g, A, M)

Sebia

The following data is part of a premarket notification filed by Sebia with the FDA for Hydrashift 2/4 Isatuximab.

Pre-market Notification Details

Device IDK203184
510k NumberK203184
Device Name:HYDRASHIFT 2/4 Isatuximab
ClassificationImmunoelectrophoretic, Immunoglobulins, (g, A, M)
Applicant Sebia 1705 Corporate Drive Suite 400 Norcross,  GA  30096
ContactKaren Anderson
CorrespondentKaren Anderson
Sebia 1705 Corporate Drive Suite 400 Norcross,  GA  30096
Product CodeCFF  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-27
Decision Date2021-11-12

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