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FDA 510(k)

cobas CTNG for use on cobas 6800/8800 systems

K-Number: K202408 · 2021-01-21

ApplicantRoche Molecular Systems, Inc.
Decision Date2021-01-21
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas CTNG for use on cobas 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 2021-01-21 under 510(k) number K202408. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas CTNG for use on cobas 6800/8800 systems?

cobas CTNG for use on cobas 6800/8800 systems is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K202408.

When did cobas CTNG for use on cobas 6800/8800 systems receive FDA 510(k) clearance?

cobas CTNG for use on cobas 6800/8800 systems received FDA 510(k) clearance on 2021-01-21, under 510(k) number K202408.

Who is the listed applicant for cobas CTNG for use on cobas 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 CTNG for use on cobas 6800/8800 systems?

The FDA product code for cobas CTNG for use on cobas 6800/8800 systems is QEP.

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: QEP)

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.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.

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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