Clearance Summary
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD received FDA 510(k) clearance under submission number K022331, sponsored by Bayer Diagnostics Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2002-09-11.
- Submission: K022331
- Applicant / Sponsor: Bayer Diagnostics Corp.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5200
- Decision date: 2002-09-11
Classification & Regulation
This clearance is catalogued under FDA product code GKL and 21 CFR 864.5200, within the Hematology review panel as a Class II device.