Cleared Traditional

IT/IF CONTROL

K101863 · Sebia · Immunology
Nov 2011
Decision
493d
Days
Class 1
Risk

About This 510(k) Submission

K101863 is an FDA 510(k) clearance for the IT/IF CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 7, 2011, 493 days after receiving the submission on July 2, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K101863 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2010
Decision Date November 07, 2011
Days to Decision 493 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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