Cleared Traditional

IMMUNOCAP ALLERGEN COMPONENTS BUNDLE

K113841 · Phadia US, Inc. · Immunology
Sep 2012
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K113841 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN COMPONENTS BUNDLE, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on September 13, 2012, 260 days after receiving the submission on December 28, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K113841 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2011
Decision Date September 13, 2012
Days to Decision 260 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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