510(k) clearance
BD Veritor System for SARS-CoV-2
- 510(k) number
- K261379
- Applicant
- BD Diagnostic Solutions / Becton, Dickinson & Company
- Decision date
- Oct 27, 2026
- Date received
- Apr 27, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Product code
- QVF
- Device type
- Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Device class
- Class II
- Regulation
- 21 CFR 866.3982
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Sparks, MD, US