Cleared Special

MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

K143483 · Sebia · Immunology
Jan 2015
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K143483 is an FDA 510(k) clearance for the MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING, 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 8, 2015, 31 days after receiving the submission on December 8, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K143483 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2014
Decision Date January 08, 2015
Days to Decision 31 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

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