The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen O215, Component Ngal-alpha-1,3-gal(alpha-gal) Thyroglobulin, Bovine.
| Device ID | K200279 |
| 510k Number | K200279 |
| Device Name: | ImmunoCAP Allergen O215, Component NGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, Bovine |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE 75137 |
| Contact | Carina Magnusson |
| Correspondent | Sheryl Skinner Phadia US Inc. 4169 Commercial Ave 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 | 2020-02-04 |
| Decision Date | 2020-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066017518 | K200279 | 000 |