Clearance Summary
MODIFICATION TO ELECSYS FSH II CALSET received FDA 510(k) clearance under submission number K012399, 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 2001-08-24.
- Submission: K012399
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2001-08-24
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.