Biomedical Diagnostics (Bmd) SA
Marne La Vallee Cedex 2, FR
Biomedical Diagnostics (Bmd) SA appears in FDA device records in Marne La Vallee Cedex 2, FR. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Biomedical Diagnostics (Bmd) SA between 2005 and 2010. The busiest year on record is 2006, with 5. The most recent is 2010, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 5 |
| 2007 | 2 |
| 2010 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | LLL | Substantially Equivalent | |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | MOB | Substantially Equivalent | |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | MOB | Substantially Equivalent | |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | LKO | Substantially Equivalent | |
| K061794 | FIDIS TM THYRO, MODEL MX002 | JZO | Substantially Equivalent | |
| K060380 | FIDIS DSDNA | LSW | Substantially Equivalent | |
| K053383 | FIDIS CELIAC | MST | Substantially Equivalent | |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | LLL | Substantially Equivalent | |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | MOB | Substantially Equivalent | |
| K050286 | FIDIS CONNECTIVE 8 | LLL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain