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FDA 510(k)

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

K-Number: K191729 · 2019-07-24

ApplicantRoche Molecular Systems, Inc.
Decision Date2019-07-24
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2019-07-24 under approval number K191729. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System?

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System is a medical device that received FDA 510(k) clearance on 2019-07-24. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K191729.

When was Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System approved by the FDA?

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System received FDA 510(k) clearance on 2019-07-24, under approval number K191729.

What company makes Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System?

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System?

The FDA product code for Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System is OCC.

Related Clinical Trials

NCT06417853 Influenza A (H7N9) Vaccine Delivered Intradermally by High-density Microarray Patch (HD-MAP) COMPLETED

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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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