Clearance Summary
Quo-Test A1c System received FDA 510(k) clearance under submission number K180509, sponsored by Ekf-Diagnostic GmbH. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2019-02-16.
- Submission: K180509
- Applicant / Sponsor: Ekf-Diagnostic GmbH
- Clearance pathway: Dual Track
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2019-02-16
Classification & Regulation
This clearance is catalogued under FDA product code LCP and 21 CFR 864.7470, within the Hematology review panel as a Class II device.