Clearance Summary
Crosstex VH2O2 Chemical Indicators received FDA 510(k) clearance under submission number K200096, sponsored by Crosstex International, Inc. (A Cantel Medical Company). The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-07-15.
- Submission: K200096
- Applicant / Sponsor: Crosstex International, Inc. (A Cantel Medical Company)
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2021-07-15
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.