Cleared Traditional

K082388 - MINICAP IMMUNOTYPING, MODEL: 2300 (FDA 510(k) Clearance)

K082388 · Sebia · Immunology device
Apr 2009
Decision
238d
Days
Class 2
Risk

K082388 is an FDA 510(k) clearance for the MINICAP IMMUNOTYPING, MODEL: 2300. This device is classified as 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 April 14, 2009, 238 days after receiving the submission on August 19, 2008.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K082388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date April 14, 2009
Days to Decision 238 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.5510