Clearance Summary
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER received FDA 510(k) clearance under submission number K103277, sponsored by 3M Company-3M Health Care. 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 2011-04-19.
- Submission: K103277
- Applicant / Sponsor: 3M Company-3M Health Care
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2011-04-19
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.