ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed— 510(k) K212181

Name: FDA 510(k) clearance K212181
Creator: U.S. Food and Drug Administration
Published: 2022-08-03

Substantially Equivalent

Phadia AB

FDA 510(k) clearance K212181 for ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed, Substantially Equivalent on 2022-08-03. Applicant: Phadia AB. Device class: 2.

Clearance details

Applicant: Phadia AB
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 2021-07-13
Decision date: 2022-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.