510(k) clearance
Xpert Respiratory Panel
- 510(k) number
- K261336
- Applicant
- Cepheid
- Decision date
- Sep 25, 2026
- Date received
- Apr 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QOF
- Device type
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II
- Regulation
- 21 CFR 866.3981
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Sunnyvale, CA, US