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FDA 510(k)

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

K-Number: K213822 · 2022-07-06

ApplicantRoche Molecular Systems, Inc.
Decision Date2022-07-06
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas Influenza A/B & RSV 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 2022-07-06 under approval number K213822. 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 & RSV nucleic acid test for use on the cobas Liat System?

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K213822.

When was cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System approved by the FDA?

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2022-07-06, under approval number K213822.

What company makes cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System?

cobas Influenza A/B & RSV 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 & RSV nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Influenza A/B & RSV 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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