SAL · Device, Automated Cell Locating, Bone Marrow
Hematology · 21 CFR 864.5261 · Class 2
Overview
| Product Code | SAL |
|---|---|
| Device Name | Device, Automated Cell Locating, Bone Marrow |
| Regulation | 21 CFR 864.5261 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An automated cell-locating device for bone marrow aspirate is an in vitro diagnostic device intended for prescription use that automatically locates and presents images of hematopoietic cells on a bone marrow aspirate smear obtained from patients being evaluated for hematologic diseases. The device assists operators to identify and classify each cell according to type.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230034 | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application | Scopio Labs , Ltd. | Mar 22, 2024 | DENG |
Top Applicants
- Scopio Labs , Ltd. — 1 clearance
