Clearance Summary
HIGH METABOLITE QUALICHECK received FDA 510(k) clearance under submission number K130415, sponsored by Radiometer Medical Aps. 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 2013-03-26.
- Submission: K130415
- Applicant / Sponsor: Radiometer Medical Aps
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2013-03-26
Classification & Regulation
This clearance is catalogued under FDA product code JJS and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.