Scopio Labs , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationJune 27, 2025
DEN230034X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow AspMarch 22, 2024
K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationMay 3, 2022
K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationOctober 2, 2020