Clearance Summary
ROCHE COBAS ARGOS 5 DIFF received FDA 510(k) clearance under submission number K912615, sponsored by Roche Diagnostic Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1991-09-27.
- Submission: K912615
- Applicant / Sponsor: Roche Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5810
- Decision date: 1991-09-27
Classification & Regulation
This clearance is catalogued under FDA product code GZI and 21 CFR 882.5810, within the Neurology review panel as a Class II device.