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FDA 510(k), K201301, X100 with Full Field Peripheral Blood Smear (PBS) Application
FDA 510(k), K201301, X100 with Full Field Peripheral Blood Smear (PBS) Application
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510(K) Number: K201301
Device Name: X100 with Full Field Peripheral Blood Smear (PBS) Application
Manufacturer: Shahar Karny
Device Classification Name: Device, Automated Cell-Locating
Regulation Number: JOY
Classification Product Code: 05/15/2020
Date Received: 10/02/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: X100 with Full Field Peripheral Blood Smear (PBS) Application
Manufacturer: Shahar Karny
Device Classification Name: Device, Automated Cell-Locating
Regulation Number: JOY
Classification Product Code: 05/15/2020
Date Received: 10/02/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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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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