MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
FDA 510(k) clearance K070458 · decided 2007-12-21
Clearance details
- K-number
- K070458
- Device name
- MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
- Applicant
- Biomedical Diagnostics (Bmd) SA
- Decision
- Substantially Equivalent
- Date received
- 2007-02-16
- Decision date
- 2007-12-21
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- MOB
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Marne La Vallee Cedex 2, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.