Scopio Labs , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application, X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application, X100 with Full Field Peripheral Blood Smear (PBS) Application
4
Total
3
Cleared
1
Denied
FDA 510(k) Regulatory Record - Scopio Labs , Ltd. Hematology ✕
4 devices
Cleared
Jun 27, 2025
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
Hematology
270d
Not Cleared
Mar 22, 2024
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with...
Hematology
329d
Cleared
May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)...
Hematology
119d
Cleared
Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
Hematology
140d