The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidis Celiac.
| Device ID | K053383 |
| 510k Number | K053383 |
| Device Name: | FIDIS CELIAC |
| Classification | Antibodies, Gliadin |
| Applicant | BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
| Contact | Courivaud Christelle |
| Correspondent | Courivaud Christelle BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-03-29 |
| Summary: | summary |