Clearance Summary
LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL received FDA 510(k) clearance under submission number K023032, sponsored by Bioresource Technology, 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 2002-10-08.
- Submission: K023032
- Applicant / Sponsor: Bioresource Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 2002-10-08
Classification & Regulation
This clearance is catalogued under FDA product code GFS and 21 CFR 864.8625, within the Hematology review panel as a Class II device.