Clearance Summary
URYXXON 200 URINE ANALYZER received FDA 510(k) clearance under submission number K051034, sponsored by Macherey-Nagel GmbH & Co. KG. 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 2005-11-22.
- Submission: K051034
- Applicant / Sponsor: Macherey-Nagel GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2005-11-22
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.