Cleared Traditional

ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE

K163370 · Phadia AB · Immunology
May 2017
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K163370 is an FDA 510(k) clearance for the ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE, 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 May 5, 2017, 155 days after receiving the submission on December 1, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K163370 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2016
Decision Date May 05, 2017
Days to Decision 155 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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