X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application— 510(k) DEN230034

Name: FDA 510(k) clearance DEN230034
Creator: U.S. Food and Drug Administration
Published: 2024-03-22

Unknown

Scopio Labs , Ltd.

FDA 510(k) clearance DEN230034 for X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application, Unknown on 2024-03-22. Applicant: Scopio Labs , Ltd.. Device class: 2.

Clearance details

Applicant: Scopio Labs , Ltd.
Product code: Code SAL
Device class: Class 2
Regulation: 21 CFR 864.5261
Advisory panel: Hematology
Date received: 2023-04-28
Decision date: 2024-03-22
Decision: Unknown
Clearance type: Direct
Location: Tel-Aviv, IL

View on FDA.gov ↗

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