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FDA 510(k)

cobas liat Bordetella panel nucleic acid test

K-Number: K243753 · 2025-11-20

ApplicantRoche Molecular Systems, Inc.
Decision Date2025-11-20
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas liat Bordetella panel nucleic acid test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-11-20 under approval number K243753. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas liat Bordetella panel nucleic acid test?

cobas liat Bordetella panel nucleic acid test is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K243753.

When was cobas liat Bordetella panel nucleic acid test approved by the FDA?

cobas liat Bordetella panel nucleic acid test received FDA 510(k) clearance on 2025-11-20, under approval number K243753.

What company makes cobas liat Bordetella panel nucleic acid test?

cobas liat Bordetella panel nucleic acid test is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas liat Bordetella panel nucleic acid test?

The FDA product code for cobas liat Bordetella panel nucleic acid test is OZZ.

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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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