FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
FDA 510(k) clearance K100917 · decided 2010-11-03
Clearance details
- K-number
- K100917
- Device name
- FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
- Applicant
- Biomedical Diagnostics (Bmd) SA
- Decision
- Substantially Equivalent
- Date received
- 2010-04-02
- Decision date
- 2010-11-03
- Days to decision
- 215 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Biomedical Diagnostics (Bmd) SA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.