The following data is part of a premarket notification filed by Biomedical Diagnostics S.a. with the FDA for Fidis Celiac.
| Device ID | K041002 |
| 510k Number | K041002 |
| Device Name: | FIDIS CELIAC |
| Classification | Antibodies, Gliadin |
| Applicant | BIOMEDICAL DIAGNOSTICS S.A. ACTIPOLE, 25-BD DE BEAUBOURG BP 103 Marne-la-vallee, Cedex 2, FR 77423 |
| Contact | Pascale Laroche |
| Correspondent | Pascale Laroche BIOMEDICAL DIAGNOSTICS S.A. ACTIPOLE, 25-BD DE BEAUBOURG BP 103 Marne-la-vallee, Cedex 2, FR 77423 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-19 |
| Decision Date | 2004-09-24 |
| Summary: | summary |