AXIS-SHIELD ANTI-CCP
FDA 510(k) clearance K110296 · decided 2011-08-18
Clearance details
- K-number
- K110296
- Device name
- AXIS-SHIELD ANTI-CCP
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-02-01
- Decision date
- 2011-08-18
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, Scotland, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.