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FDA 510(k), K071671, SCANSCOPE XT SYSTEM
FDA 510(k), K071671, SCANSCOPE XT SYSTEM
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510(K) Number: K071671
Device Name: SCANSCOPE XT SYSTEM
Manufacturer: APERIO TECHNOLOGIES
Device Classification Name: automated digital image manual interpretation microscope
Regulation Number: 864.1860
Classification Product Code: OEO
Date Received: 06/19/2007
Decision Date: 12/28/2007
Regulation Medical Specialty: Hematology
Device Name: SCANSCOPE XT SYSTEM
Manufacturer: APERIO TECHNOLOGIES
Device Classification Name: automated digital image manual interpretation microscope
Regulation Number: 864.1860
Classification Product Code: OEO
Date Received: 06/19/2007
Decision Date: 12/28/2007
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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