Clearance Summary
3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 received FDA 510(k) clearance under submission number DEN230068, sponsored by 3M Company. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-05-21.
- Submission: DEN230068
- Applicant / Sponsor: 3M Company
- Clearance pathway: Direct
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2801
- Decision date: 2024-05-21
Classification & Regulation
This clearance is catalogued under FDA product code SBE and 21 CFR 880.2801, within the General Hospital review panel as a Class II device.