SAL — Device, Automated Cell Locating, Bone Marrow Class II
Classification Details
- Product Code
- SAL
- Device Class
- Class II
- Regulation Number
- 864.5261
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230034 | scopio labs | X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full F | March 22, 2024 |