SCANSCOPE XT SYSTEM
FDA 510(k) clearance K080564 · decided 2009-08-14
Clearance details
- K-number
- K080564
- Device name
- SCANSCOPE XT SYSTEM
- Applicant
- Aperio Technologies
- Decision
- Substantially Equivalent
- Date received
- 2008-02-28
- Decision date
- 2009-08-14
- Days to decision
- 533 days
- Clearance type
- Traditional
- Product code
- NOT
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.