The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01.
| Device ID | K062787 |
| 510k Number | K062787 |
| Device Name: | ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| 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 | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010700 | K062787 | 000 |
| 07333066010694 | K062787 | 000 |
| 07333066013794 | K062787 | 000 |
| 07333066013787 | K062787 | 000 |
| 07333066013770 | K062787 | 000 |
| 07333066013763 | K062787 | 000 |
| 07333066013695 | K062787 | 000 |
| 07333066013688 | K062787 | 000 |
| 07333066020075 | K062787 | 000 |