510(k) DEN230034
DEN230034 is an FDA 510(k) premarket notification submitted by Scopio Labs , Ltd. for the device "X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application". The FDA issued a decision of De Novo Granted on March 22, 2024. The device falls under product code SAL (Device, Automated Cell Locating, Bone Marrow), a Class II device regulated under 21 CFR 864.5261. Scopio Labs , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 22, 2024
- Date Received
- April 28, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Cell Locating, Bone Marrow
- Device Class
- Class II
- Regulation Number
- 864.5261
- Review Panel
- HE
- Submission Type
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.