CCPOINT
FDA 510(k) clearance K093908 · decided 2010-12-01
Clearance details
- K-number
- K093908
- Device name
- CCPOINT
- Applicant
- Euro-Diagnostica AB
- Decision
- Substantially Equivalent
- Date received
- 2009-12-22
- Decision date
- 2010-12-01
- Days to decision
- 344 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.