Clearance Summary
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY received FDA 510(k) clearance under submission number K043318, sponsored by Roche Diagnostics Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2004-12-23.
- Submission: K043318
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1295
- Decision date: 2004-12-23
Classification & Regulation
This clearance is catalogued under FDA product code CGN and 21 CFR 862.1295, within the Clinical Chemistry review panel as a Class II device.