The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Specific Ige, Immunocap Allergen F447, Allergen Component Rara H 6, Peanut.
| Device ID | K173726 |
| 510k Number | K173726 |
| Device Name: | ImmunoCAP Specific IgE, ImmunoCAP Allergen F447, Allergen Component RAra H 6, Peanut |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | Phadia AB Rapsgatan 7P Uppsala, SE 75137 |
| Contact | Ulf Karlberg |
| 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 | 2017-12-05 |
| Decision Date | 2018-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066016009 | K173726 | 000 |