FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
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
K Number: K212181
·
Decision Aug 3, 2022
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
265
Applicant Total
32
Review Days
386
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Basic Information
- 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
- K Number
- K212181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phadia AB
- Date Received
- July 13, 2021
- Decision Date
- August 3, 2022
- Product Code
- DHB
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHB), ordered by most recent decision date.
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
FDA 510(k)
FDA Class 2
·Immunology
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)
FDA 510(k)
FDA Class 2
·Immunology
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
FDA 510(k)
FDA Class 2
·Immunology
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
FDA 510(k)
FDA Class 2
·Immunology
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
FDA 510(k)
FDA Class 2
·Immunology
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Phadia AB
| K Number | Device Name | ||
|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60 | Jul 27, 2022 | Substantially Equivalent |
| K202540 | EliA Rib-P | Sep 13, 2021 | Substantially Equivalent |
| K202541 | EliA RNA Pol III | Sep 13, 2021 | Substantially Equivalent |
| K202067 | EliA SmDP-S | Jul 14, 2021 | Substantially Equivalent |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | May 1, 2020 | Substantially Equivalent |
| K190710 | EliA SymphonyS Immunoassay | Nov 29, 2019 | Substantially Equivalent |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | May 14, 2019 | Substantially Equivalent |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay | Mar 1, 2019 | Substantially Equivalent |
| K183007 | EliA SmDP Immunoassay | Dec 24, 2018 | Substantially Equivalent |
| K182747 | EliA RF IgM Immunoassay | Dec 18, 2018 | Substantially Equivalent |