FDA 510(k)

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

N.º K: K223783 · 2023-12-04

SolicitanteRoche Molecular Systems, Inc.

Fecha de decisión2023-12-04

Código de productoQWR

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Otros registros que enlistan a Roche Molecular Systems, Inc. como solicitante

K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260021cobas® BV/CV K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems K253759cobas liat CT/NG/MG nucleic acid test K253756cobas liat CT/NG nucleic acid test

Ver todos los 36 dispositivos →

Dispositivos relacionados (Código: QWR)

K243346cobas liat SARS-CoV-2 v2 nucleic acid testRoche Molecular Systems, Inc.K221925ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.