Clearance Summary
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack received FDA 510(k) clearance under submission number K183294, sponsored by STERIS Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2019-01-03.
- Submission: K183294
- Applicant / Sponsor: STERIS Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2019-01-03
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.