510(k) K243144
K243144 is an FDA 510(k) premarket notification submitted by Scopio Labs , Ltd. for the device "X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application". The FDA issued a decision of Substantially Equivalent on June 27, 2025. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Scopio Labs , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2025
- Date Received
- September 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Automated Cell-Locating
- Device Class
- Class II
- Regulation Number
- 864.5260
- Review Panel
- HE
- Submission Type