Cleared Traditional

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut

K173726 · Phadia AB · Immunology
Apr 2018
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K173726 is an FDA 510(k) clearance for the ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on April 16, 2018, 132 days after receiving the submission on December 5, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K173726 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2017
Decision Date April 16, 2018
Days to Decision 132 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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