Atlas FDA

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

FDA 510(k) clearance K212181 · decided 2022-08-03

Clearance details

K-number
K212181
Device name
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
Applicant
Phadia AB
Decision
Substantially Equivalent
Date received
2021-07-13
Decision date
2022-08-03
Days to decision
386 days
Clearance type
Traditional
Product code
DHB
Device class
2
Regulation number
866.5750
Medical specialty
Immunology
Advisory committee
Immunology
Location
Uppsala, SE
Third-party review
No
Expedited review
No

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RecordFirmDate
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NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg (K260280)Hycor Biomedical2026-06-18
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Recalls involving this device

No recalls on record reference this clearance.