Cleared Traditional

CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

K161928 · Sebia · Immunology
Dec 2016
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K161928 is an FDA 510(k) clearance for the CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF 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 December 21, 2016, 160 days after receiving the submission on July 14, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K161928 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2016
Decision Date December 21, 2016
Days to Decision 160 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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