Clearance Summary
G5 I HBA1C TEST, G5 II HBA1C TEST received FDA 510(k) clearance under submission number K041635, sponsored by Provalis Diagnostics , 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 2004-08-16.
- Submission: K041635
- Applicant / Sponsor: Provalis Diagnostics , Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2004-08-16
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.