The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Specific Ige Control L, Immunocap Specific Ige Control M And Immunocap Specific Ige Control H.
| Device ID | K131738 |
| 510k Number | K131738 |
| Device Name: | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | PHADIA AB RAPSGATAN 7 P.O. BOX 6460 Uppsala, SE Se - 75137 |
| Contact | Carina Magnusson |
| Correspondent | Carina Magnusson PHADIA AB RAPSGATAN 7 P.O. BOX 6460 Uppsala, SE Se - 75137 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-13 |
| Decision Date | 2013-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066000978 | K131738 | 000 |
| 07333066000954 | K131738 | 000 |
| 07333066000930 | K131738 | 000 |