meddevicedb.com FDA Device Reference

X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application

DEN230034 Class II Direct
Decision Date
2024-03-22
Sponsor / Applicant
Scopio Labs , Ltd.

Technical Specification

510(k) Submission ID DEN230034
Product Code SAL
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.5261
Decision Date 2024-03-22
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application received FDA 510(k) clearance under submission number DEN230034, sponsored by Scopio Labs , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2024-03-22.

Classification & Regulation

This clearance is catalogued under FDA product code SAL and 21 CFR 864.5261, within the Hematology review panel as a Class II device.