Clearance Summary
URYXXON RELAX URINE ANALYZER received FDA 510(k) clearance under submission number K061742, sponsored by Macherey-Nagel GmbH & Co. KG. 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 2006-09-06.
- Submission: K061742
- Applicant / Sponsor: Macherey-Nagel GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2006-09-06
Classification & Regulation
This clearance is catalogued under FDA product code JIL and 21 CFR 862.1340, within the Clinical Chemistry review panel as a Class II device.