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FDA 510(k)

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 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 2023-12-04 under 510(k) 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. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K223783.

When did cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System receive FDA 510(k) clearance?

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2023-12-04, under 510(k) number K223783.

Who is the listed applicant for cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System?

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 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.

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Related Devices (Code: QWR)

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.

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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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