The following data is part of a premarket notification filed by Phadia Ab with the FDA for Immunocap Total Ige: Conjugate, Anti-ige, Calibrators, Curve Controls, Control Lmh.
| Device ID | K133404 |
| 510k Number | K133404 |
| Device Name: | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | PHADIA AB 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann PHADIA AB 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2014-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066000336 | K133404 | 000 |
| 07333066000206 | K133404 | 000 |
| 07333066000220 | K133404 | 000 |
| 07333066000367 | K133404 | 000 |
| 07333066019512 | K133404 | 000 |
| 07333066019529 | K133404 | 000 |
| 07333066019642 | K133404 | 000 |
| 07333066019673 | K133404 | 000 |
| 07333066004037 | K133404 | 000 |
| 07333066000022 | K133404 | 000 |
| 07333066000664 | K133404 | 000 |