Cleared Traditional

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

K200279 · Phadia AB · Immunology
May 2020
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K200279 is an FDA 510(k) clearance for the ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine, 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 1, 2020, 87 days after receiving the submission on February 4, 2020. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K200279 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2020
Decision Date May 01, 2020
Days to Decision 87 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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