The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidis Connective 10, Model Mx006.
| Device ID | K053653 |
| 510k Number | K053653 |
| Device Name: | FIDIS CONNECTIVE 10, MODEL MX006 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| 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 | LLL |
| Subsequent Product Code | LJM |
| Subsequent Product Code | LKJ |
| Subsequent Product Code | LKO |
| Subsequent Product Code | LKP |
| Subsequent Product Code | LSW |
| Subsequent Product Code | MQA |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-30 |
| Decision Date | 2006-03-13 |
| Summary: | summary |