The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Immunocap Specific Ige Allergen Bundle, 12 Allergen Components.
| Device ID | K111919 |
| 510k Number | K111919 |
| Device Name: | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin Mann |
| 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 | 2011-07-07 |
| Decision Date | 2011-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010533 | K111919 | 000 |
| 07333066005706 | K111919 | 000 |
| 07333066008738 | K111919 | 000 |
| 07333066008752 | K111919 | 000 |
| 07333066008844 | K111919 | 000 |
| 07333066008868 | K111919 | 000 |
| 07333066009599 | K111919 | 000 |
| 07333066009636 | K111919 | 000 |
| 07333066009650 | K111919 | 000 |
| 07333066009698 | K111919 | 000 |
| 07333066010441 | K111919 | 000 |
| 07333066005584 | K111919 | 000 |