The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Specific Ige; Immunocap Allergen F439, Hazelnut; Immunocap Allergen F440, Hazelnut; Immunocap Allergen F441, Walnut; Immunocap Allergen F442, Walnut; Immunocap Allergen F443, Cashew Nut.
| Device ID | K150854 |
| 510k Number | K150854 |
| Device Name: | ImmunoCAP Specific IgE; ImmunoCAP Allergen F439, Hazelnut; ImmunoCAP Allergen F440, Hazelnut; ImmunoCAP Allergen F441, Walnut; ImmunoCAP Allergen F442, Walnut; ImmunoCAP Allergen F443, Cashew Nut |
| 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 | 2015-03-31 |
| Decision Date | 2015-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066011059 | K150854 | 000 |
| 07333066011042 | K150854 | 000 |
| 07333066011035 | K150854 | 000 |
| 07333066011028 | K150854 | 000 |
| 07333066011004 | K150854 | 000 |