X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
FDA 510(k) clearance DEN230034 · decided 2024-03-22
Clearance details
- K-number
- DEN230034
- Device name
- X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
- Applicant
- Scopio Labs , Ltd.
- Decision
- Unknown
- Date received
- 2023-04-28
- Decision date
- 2024-03-22
- Days to decision
- 329 days
- Clearance type
- Direct
- Product code
- SAL
- Device class
- 2
- Regulation number
- 864.5261
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tel-Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.