Cleared Traditional

ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat

K190315 · Phadia AB · Immunology
May 2019
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K190315 is an FDA 510(k) clearance for the ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat, 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 14, 2019, 90 days after receiving the submission on February 13, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K190315 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2019
Decision Date May 14, 2019
Days to Decision 90 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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