Clearance Summary
SPOR-TEST PA BIOLOGICAL INDICATOR KIT received FDA 510(k) clearance under submission number K050664, sponsored by Getinge USA, Inc.. 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 2005-04-07.
- Submission: K050664
- Applicant / Sponsor: Getinge USA, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2005-04-07
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.