The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, Allergen.
| Device ID | K101251 |
| 510k Number | K101251 |
| Device Name: | IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN |
| 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 | 2010-05-04 |
| Decision Date | 2011-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010540 | K101251 | 000 |
| 07333066005539 | K101251 | 000 |
| 07333066005546 | K101251 | 000 |
| 07333066005553 | K101251 | 000 |
| 07333066005560 | K101251 | 000 |
| 07333066005577 | K101251 | 000 |
| 07333066005591 | K101251 | 000 |
| 07333066005638 | K101251 | 000 |
| 07333066005690 | K101251 | 000 |
| 07333066005737 | K101251 | 000 |
| 07333066008929 | K101251 | 000 |
| 07333066010496 | K101251 | 000 |
| 07333066004808 | K101251 | 000 |