510(k) K230878
K230878 is an FDA 510(k) premarket notification submitted by Ad Astra Diagnostics, Inc. for the device "QScout Lab; QScout RLD". The FDA issued a decision of Substantially Equivalent on November 14, 2023. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2023
- Date Received
- March 30, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type