Clearance Summary
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) received FDA 510(k) clearance under submission number K973369, sponsored by Roche Diagnostic Systems, Inc.. 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 1997-11-21.
- Submission: K973369
- Applicant / Sponsor: Roche Diagnostic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1997-11-21
Classification & Regulation
This clearance is catalogued under FDA product code LBR and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.