Clearance Summary
HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 received FDA 510(k) clearance under submission number K060765, sponsored by Hemocue AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-09-06.
- Submission: K060765
- Applicant / Sponsor: Hemocue AB
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2006-09-06
Classification & Regulation
This clearance is catalogued under FDA product code LFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.