Product code SAL— Hematology
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
- Classification name
- Device, Automated Cell Locating, Bone Marrow
- Device class
- Class 2
- Regulation
- 21 CFR 864.5261
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SAL
FDA has cleared device under product code SAL, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SAL
Recent clearances under product code SAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.