Clearance Summary
SporView Rapid Read Biological Indicator SteamPlus Test Pack received FDA 510(k) clearance under submission number K181434, sponsored by Crosstex/Spsmedical, A Division of Cantel Medical. 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 2018-11-14.
- Submission: K181434
- Applicant / Sponsor: Crosstex/Spsmedical, A Division of Cantel Medical
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2018-11-14
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.