510(k) DEN230034

Device

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

Applicant

Scopio Labs , Ltd.

510(k) number

DEN230034

Product code

SAL

Decision

Unknown (DENG)

Decision date

2024-03-22

Date received

2023-04-28

Regulation

864.5261

Classification name

Device, Automated Cell Locating, Bone Marrow

Medical specialty

Hematology

Review panel

Hematology

Device class

2

Clearance type

Direct

Third party reviewed

N