SAL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Automated Cell Locating, Bone Marrow
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5261
- Medical specialty
- Hematology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application (DEN230034) | Scopio Labs , Ltd. | 2024-03-22 |
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Every clearance here is in the API, with alerts when new ones post.