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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 the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) 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. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K243753.

When did cobas liat Bordetella panel nucleic acid test receive FDA 510(k) clearance?

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

Who is the listed applicant for cobas liat Bordetella panel nucleic acid test?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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NCT07221097Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other CoronavirusesCOMPLETED

Other records listing Roche Molecular Systems, Inc. as applicant

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Related Devices (Code: OZZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK181029Solana Bordetella Complete AssayQuidel CorporationK163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex CorporationK170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc.

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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