Clearance Summary
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS received FDA 510(k) clearance under submission number K113302, sponsored by North American Science Assoc., Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-01-20.
- Submission: K113302
- Applicant / Sponsor: North American Science Assoc., Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2012-01-20
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.