The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01.
| Device ID | K062583 |
| 510k Number | K062583 |
| Device Name: | ELIA CELIKEY IGG WELL, MODEL 14-5518-01, 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 | 2006-09-01 |
| Decision Date | 2006-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010717 | K062583 | 000 |