510(k) Report

Devices descending from K201301

2 later devices reach X100 with Full Field Peripheral Blood Smear (PBS) Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20250—
+1K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20221—