The following data is part of a premarket notification filed by Biomedical Diagnostics (bmd) Sa with the FDA for Fidistm Connective 10, Fidistm Analyzer, Caris.
| Device ID | K102607 |
| 510k Number | K102607 |
| Device Name: | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS |
| 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 | 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 | 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 |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2010-12-03 |
| Summary: | summary |