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FDA 510(k)

cobas® liat CT/NG/MG nucleic acid test

K-Number: K240197 · 2025-01-16

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-01-16
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas® liat CT/NG/MG nucleic acid test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-01-16 under approval number K240197. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas® liat CT/NG/MG nucleic acid test?

cobas® liat CT/NG/MG nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K240197.

When was cobas® liat CT/NG/MG nucleic acid test approved by the FDA?

cobas® liat CT/NG/MG nucleic acid test received FDA 510(k) clearance on 2025-01-16, under approval number K240197.

What company makes cobas® liat CT/NG/MG nucleic acid test?

cobas® liat CT/NG/MG nucleic acid test is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas® liat CT/NG/MG nucleic acid test?

The FDA product code for cobas® liat CT/NG/MG nucleic acid test is QEP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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