The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Immunocap Allergen Components Bundle.
| Device ID | K113841 |
| 510k Number | K113841 |
| Device Name: | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE |
| 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 | 2011-12-28 |
| Decision Date | 2012-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010939 | K113841 | 000 |
| 07333066010915 | K113841 | 000 |
| 07333066010519 | K113841 | 000 |
| 07333066010397 | K113841 | 000 |
| 07333066005713 | K113841 | 000 |
| 07333066005614 | K113841 | 000 |
| 07333066005522 | K113841 | 000 |
| 07333066005515 | K113841 | 000 |
| 07333066005508 | K113841 | 000 |