Clearance Summary
ADVIA CHEMISTRY MICROALBUMIN CONTROLS received FDA 510(k) clearance under submission number K052242, sponsored by Bayer Healthcare, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2005-10-03.
- Submission: K052242
- Applicant / Sponsor: Bayer Healthcare, LLC
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2005-10-03
Classification & Regulation
This clearance is catalogued under FDA product code JJW and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.