510(k) K231465
K231465 is an FDA 510(k) premarket notification submitted by Qurasense for the device "Q-Pad Test System". The FDA issued a decision of Substantially Equivalent on December 6, 2023. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2023
- Date Received
- May 19, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type