Cleared Traditional

HYDRASHIFT 2/4 daratumumab, daratumumab Control

K172195 · Sebia · Immunology
Jan 2018
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K172195 is an FDA 510(k) clearance for the HYDRASHIFT 2/4 daratumumab, daratumumab Control, 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 January 11, 2018, 174 days after receiving the submission on July 21, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K172195 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2017
Decision Date January 11, 2018
Days to Decision 174 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

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