Advanced RBC Application
FDA 510(k) clearance K171315 · decided 2017-08-01
Clearance details
- K-number
- K171315
- Device name
- Advanced RBC Application
- Applicant
- CellaVision AB
- Decision
- Substantially Equivalent
- Date received
- 2017-05-04
- Decision date
- 2017-08-01
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JOY
- Device class
- 2
- Regulation number
- 864.5260
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lund, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.