FIDIS TM THYRO, MODEL MX002
FDA 510(k) clearance K061794 · decided 2006-11-21
Clearance details
- K-number
- K061794
- Device name
- FIDIS TM THYRO, MODEL MX002
- Applicant
- Biomedical Diagnostics (Bmd) SA
- Decision
- Substantially Equivalent
- Date received
- 2006-06-26
- Decision date
- 2006-11-21
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- JZO
- Device class
- 2
- Regulation number
- 866.5870
- 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.