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Scopio Labs , Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application510(k)Jun 27, 2025Hematology
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application510(k)Mar 22, 2024Hematology
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application510(k)May 3, 2022Hematology

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