Cleared Special

HYDRASHIFT 2/4 daratumumab

K190851 · Sebia · Immunology
May 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K190851 is an FDA 510(k) clearance for the HYDRASHIFT 2/4 daratumumab, 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 May 2, 2019, 30 days after receiving the submission on April 2, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K190851 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2019
Decision Date May 02, 2019
Days to Decision 30 days
Submission Type Special
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
HYDRASHIFT 2/4 isatuximab
K203184 · Sebia · Nov 2021
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · Sebia · Nov 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