Clearance Summary
LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR received FDA 510(k) clearance under submission number K033899, sponsored by Lifestream Technologies, 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 2004-05-20.
- Submission: K033899
- Applicant / Sponsor: Lifestream Technologies, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 2004-05-20
Classification & Regulation
This clearance is catalogued under FDA product code NFX and 21 CFR 862.1175, within the Clinical Chemistry review panel as a Class I device.