510(k) clearance
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
- 510(k) number
- K262432
- Applicant
- CorDx, Inc.
- Decision date
- Oct 14, 2026
- Date received
- Jul 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SCA
- Device type
- Multi-Analyte Respiratory Virus Antigen Detection Test
- Device class
- Class II
- Regulation
- 21 CFR 866.3987
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Alpharetta, GA, US