Clearance Summary
HEMOCUE HBA1C 501 received FDA 510(k) clearance under submission number K121366, sponsored by Infopia Co, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2012-09-07.
- Submission: K121366
- Applicant / Sponsor: Infopia Co, Ltd.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7470
- Decision date: 2012-09-07
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.