Clearance Summary
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM received FDA 510(k) clearance under submission number K053253, 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 2006-02-17.
- Submission: K053253
- Applicant / Sponsor: Hemocue AB
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2900
- Decision date: 2006-02-17
Classification & Regulation
This clearance is catalogued under FDA product code KQO and 21 CFR 862.2900, within the Clinical Chemistry review panel as a Class I device.