Cleared Traditional

HYDRASHIFT 2/4 isatuximab

K203184 · Sebia · Immunology
Nov 2021
Decision
381d
Days
Class 2
Risk

About This 510(k) Submission

K203184 is an FDA 510(k) clearance for the HYDRASHIFT 2/4 isatuximab, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 12, 2021, 381 days after receiving the submission on October 27, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K203184 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2020
Decision Date November 12, 2021
Days to Decision 381 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 28
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · Sebia · Nov 2019
HYDRASHIFT 2/4 daratumumab
K190851 · Sebia · May 2019
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · Sebia · Jan 2018
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · Sebia · Dec 2016
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · Sebia · Jan 2015
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · Grifols USA, LLC · Aug 2012