Clearance Summary
BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System received FDA 510(k) clearance under submission number K230956, sponsored by Bd Integrated Diagnostic Solutions /. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-07-31.
- Submission: K230956
- Applicant / Sponsor: Bd Integrated Diagnostic Solutions /
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3981
- Decision date: 2023-07-31
Classification & Regulation
This clearance is catalogued under FDA product code QOF and 21 CFR 866.3981, within the Microbiology review panel as a Class II device.