Clearance Summary
QWIKCHECK-BEADS received FDA 510(k) clearance under submission number K041600, sponsored by Medical Electronics Systems , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-07-27.
- Submission: K041600
- Applicant / Sponsor: Medical Electronics Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 2004-07-27
Classification & Regulation
This clearance is catalogued under FDA product code NRF and 21 CFR 864.8625, within the Hematology review panel as a Class II device.