ImmunoCAP Specific IgE +5 more— 510(k) K150854
Substantially EquivalentPhadia AB
FDA 510(k) clearance K150854 for ImmunoCAP Specific IgE +5 more, Substantially Equivalent on 2015-12-14. Applicant: Phadia AB. Device class: 2.
Clearance details
- Device name as filed
- ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut
- Applicant
- Phadia AB
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code DHB
view allMore clearances from Phadia AB
view all- K253367 — EliA CTD 13 Screen
- K212181 — 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
- K210902 — EliA Ro52, EliA Ro60
- K202540 — EliA Rib-P
- K202541 — EliA RNA Pol III
Data sourced from openFDA. This site is unofficial and independent of the FDA.