The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Gliadin Iga, Igg And Celiac Control.
| Device ID | K063775 |
| 510k Number | K063775 |
| Device Name: | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL |
| Classification | Antibodies, Gliadin |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010731 | K063775 | 000 |
| 07333066010724 | K063775 | 000 |
| 07333066013909 | K063775 | 000 |
| 07333066013855 | K063775 | 000 |