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FDA 510(k)

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

K-Number: K231306 · 2023-06-01

ApplicantRoche Molecular Systems, Inc.
Decision Date2023-06-01
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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.

NCT06099795Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2RECRUITING

Other records listing Roche Molecular Systems, Inc. as applicant

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.

K260021cobas® BV/CVK260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsPMA P190028KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSK253759cobas liat CT/NG/MG nucleic acid testK253756cobas liat CT/NG nucleic acid testPMA P140023Somatic gene mutation detection system

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Related Devices (Code: QQX)

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.

K243396Aptima SARS-CoV-2 AssayHologic, 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 MolecularK233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies CorporationK230440Xpert® Xpress CoV-2 plusCepheid®

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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