Cleared Traditional

ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut

K150854 · Phadia AB · Immunology
Dec 2015
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K150854 is an FDA 510(k) clearance for the ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut, 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 December 14, 2015, 258 days after receiving the submission on March 31, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K150854 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2015
Decision Date December 14, 2015
Days to Decision 258 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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