The following data is part of a premarket notification filed by Phadia Ab with the FDA 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.
| Device ID | K212181 |
| 510k 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 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE 75137 |
| Contact | Anna Torell Holm |
| Correspondent | Tosha Dave Phadia US Inc 4169 Commercial Avenue Portage, MI 49002 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-13 |
| Decision Date | 2022-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066021706 | K212181 | 000 |
| 07333066010922 | K212181 | 000 |
| 07333066005454 | K212181 | 000 |