cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K-Number: K223783 · 2023-12-04
ApplicantRoche Molecular Systems, Inc.
Decision Date2023-12-04
Product CodeQWR
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
cobas SARS-CoV-2 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 2023-12-04 under approval number K223783. The device is classified under product code QWR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System?
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2023-12-04. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K223783.
When was cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System approved by the FDA?
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2023-12-04, under approval number K223783.
What company makes cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System?
cobas SARS-CoV-2 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 SARS-CoV-2 Nucleic acid test for use on the cobas Liat System?
The FDA product code for cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System is QWR.
Other Devices by Roche Molecular Systems, Inc.
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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.