The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen W1, Common Ragweed; Immunocap Specific Ige.
| Device ID | K163370 |
| 510k Number | K163370 |
| Device Name: | ImmunoCAP Allergen W1, Common Ragweed; ImmunoCAP Specific IgE |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA AB Rapsgatan 7P Uppsala, SE 75137 |
| Contact | Carina Magnusson |
| Correspondent | Martin Mann 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 | 2016-12-01 |
| Decision Date | 2017-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066015903 | K163370 | 000 |