The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidis Tm Thyro, Model Mx002.
| Device ID | K061794 |
| 510k Number | K061794 |
| Device Name: | FIDIS TM THYRO, MODEL MX002 |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
| Contact | Christelle Courivaud |
| Correspondent | Christelle Courivaud BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-11-21 |
| Summary: | summary |