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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name device, automated cell locating, bone marrow
De Novo Number DEN230034
Device Name X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
Requester
scopio labs , ltd.
10 hasharon st.
tel-aviv,  IL 6618502
Contact shahar karny
Regulation Number864.5261
Classification Product Code
SAL  
Date Received04/28/2023
Decision Date 03/22/2024
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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