cobas liat CT/NG nucleic acid test— 510(k) K253756
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K253756 for cobas liat CT/NG nucleic acid test, Substantially Equivalent on 2026-05-15. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Summary
Roche Molecular Systems' cobas liat CT/NG nucleic acid test is filed under QEP, nucleic acid detection systems for non-viral microorganisms causing sexually transmitted infections. The record doesn't expand "CT/NG".
Class II, 21 CFR 866.3393. Microbiology is both the classification panel and the review panel. The record lists the submission type as Dual Track.
Roche filed from Pleasanton, California. The decision came 171 calendar days after receipt (November 25, 2025 to May 15, 2026).
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product 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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