510(k) clearance
cobas eplex respiratory pathogen panel 3
- 510(k) number
- K262938
- Applicant
- GenMark Diagnostics, Inc.
- Decision date
- Oct 30, 2026
- Date received
- Aug 21, 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
- Carlsbad, CA, US