Cleared Traditional

CAPI 3 Immunotyping, Capillarys 3 Tera

K192095 · Sebia · Immunology
Nov 2019
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K192095 is an FDA 510(k) clearance for the CAPI 3 Immunotyping, Capillarys 3 Tera, 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 1, 2019, 88 days after receiving the submission on August 5, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K192095 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2019
Decision Date November 01, 2019
Days to Decision 88 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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