Clearance Summary
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 received FDA 510(k) clearance under submission number K140150, sponsored by Hmd Biomedical, Inc.. 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 2015-05-14.
- Submission: K140150
- Applicant / Sponsor: Hmd Biomedical, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2015-05-14
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.