Clearance Summary
VARIANT II HEMOGLOBIN A1C received FDA 510(k) clearance under submission number K040872, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-04-15.
- Submission: K040872
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2004-04-15
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.