FDA 510(k)

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

N.º K: K231306 · 2023-06-01

SolicitanteRoche Molecular Systems, Inc.

Fecha de decisión2023-06-01

Código de productoQQX

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems 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 2023-06-01 under 510(k) number K231306. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems?

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K231306.

When did cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems receive FDA 510(k) clearance?

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems received FDA 510(k) clearance on 2023-06-01, under 510(k) number K231306.

Who is the listed applicant for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems?

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 Qualitative for use on the cobas 5800/6800/8800 Systems?

The FDA product code for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems is QQX.

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

K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)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)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 K253756cobas liat CT/NG nucleic acid test K253759cobas liat CT/NG/MG nucleic acid test

Ver todos los 36 dispositivos →

Dispositivos relacionados (Código: QQX)

K243396Aptima Ensayo de SARS-CoV-2Hologic, Inc.K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular K233453Kit de Diagnóstico PCR de COVID-19 TaqPath™ de Applied Biosystems™Life Technologies Corporation K230440Xpert® Xpress CoV-2 plusCepheid®

Fuente oficial

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