ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE— 510(k) K163370
Substantially EquivalentPhadia AB
FDA 510(k) clearance K163370 for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE, Substantially Equivalent on 2017-05-05. Applicant: Phadia AB. Device class: 2.
Clearance details
- Applicant
- Phadia AB
- Product code
- Product 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.