Cleared Traditional

K082085 - CAPILLARYS IMMUNOTYPING, MODEL 2100 (FDA 510(k) Clearance)

K082085 · Sebia · Immunology device
Apr 2009
Decision
268d
Days
Class 2
Risk

K082085 is an FDA 510(k) clearance for the CAPILLARYS IMMUNOTYPING, MODEL 2100. 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 17, 2009, 268 days after receiving the submission on July 23, 2008.

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

Submission Details

510(k) Number K082085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2008
Decision Date April 17, 2009
Days to Decision 268 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