FDA 510(k) Application Details - DEN230034

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230034
Device Name	X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
Applicant	Scopio Labs Ltd. 10 Hasharon Street Tel-Aviv 6618502 IL Other 510(k) Applications for this Company
Contact	Shahar Karny Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2023
Decision Date	03/22/2024
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review