Clearance Summary
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 received FDA 510(k) clearance under submission number DEN150057, sponsored by Roche Diagnostics. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2016-12-19.
- Submission: DEN150057
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Direct
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1092
- Decision date: 2016-12-19
Classification & Regulation
This clearance is catalogued under FDA product code PQO and 21 CFR 862.1092, within the Clinical Chemistry review panel as a Class II device.