cobas liat CT/NG/MG nucleic acid test— 510(k) K253759
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K253759 for cobas liat CT/NG/MG nucleic acid test, Substantially Equivalent on 2026-05-15. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QEP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3393
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Pleasanton, CA, US
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