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FDA 510(k), K190332, Aperio AT2 DX System
FDA 510(k), K190332, Aperio AT2 DX System
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510(K) Number: K190332
Device Name: Aperio AT2 DX System
Manufacturer: Leica Biosystems Imaging, Inc.
Device Classification Name: whole slide imaging system
Regulation Number: 864.3700
Classification Product Code: PSY
Date Received: 02/14/2019
Decision Date: 05/20/2019
Regulation Medical Specialty: Pathology
Device Name: Aperio AT2 DX System
Manufacturer: Leica Biosystems Imaging, Inc.
Device Classification Name: whole slide imaging system
Regulation Number: 864.3700
Classification Product Code: PSY
Date Received: 02/14/2019
Decision Date: 05/20/2019
Regulation Medical Specialty: Pathology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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