Clearance Summary
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR received FDA 510(k) clearance under submission number DEN110006, sponsored by STERIS Corporation. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2013-07-12.
- Submission: DEN110006
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Post-NSE
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2805
- Decision date: 2013-07-12
Classification & Regulation
This clearance is catalogued under FDA product code OWP and 21 CFR 880.2805, within the General Hospital review panel as a Class II device.