Clearance Summary
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR received FDA 510(k) clearance under submission number K051056, sponsored by Albert Browne , Ltd.. 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 2005-10-20.
- Submission: K051056
- Applicant / Sponsor: Albert Browne , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2005-10-20
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.