X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144)
Description
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application by Scopio Labs , Ltd., an FDA 510(k) cleared hematology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243144
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220013 | X100HT with Slide Loader with Full Field Peripheral Blood S... | Scopio Labs , Ltd. | 2022 |
| K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | 2020 |
Trace the full predicate network for K243144
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.