Clearance Summary
CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT received FDA 510(k) clearance under submission number K020205, sponsored by Getinge/Castle, Inc.. 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 2002-06-24.
- Submission: K020205
- Applicant / Sponsor: Getinge/Castle, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2002-06-24
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.