Clearance Summary
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System received FDA 510(k) clearance under submission number K220421, sponsored by Apex BioTechnology Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2022-11-04.
- Submission: K220421
- Applicant / Sponsor: Apex BioTechnology Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2022-11-04
Classification & Regulation
This clearance is catalogued under FDA product code NBW and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.