The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen F20, Almond Model: 14-4179-01.
| Device ID | K100999 |
| 510k Number | K100999 |
| Device Name: | IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA AB 4169 COMMERCIAL AVENUE Portage, MI 49002 |
| Contact | Martin Mann |
| Correspondent | Martin Mann PHADIA AB 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 | 2010-04-12 |
| Decision Date | 2010-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066001784 | K100999 | 000 |