Clearance Summary
INFLUENZA A/B RAPID TEST, CAT NO 2158 663 received FDA 510(k) clearance under submission number K011684, sponsored by Roche Diagnostics Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2001-11-30.
- Submission: K011684
- Applicant / Sponsor: Roche Diagnostics Corp.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3328
- Decision date: 2001-11-30
Classification & Regulation
This clearance is catalogued under FDA product code PSZ and 21 CFR 866.3328, within the Microbiology review panel as a Class II device.