Clearance Summary
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 received FDA 510(k) clearance under submission number K063400, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2006-12-01.
- Submission: K063400
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2006-12-01
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.