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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 a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2021-01-21 under approval 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. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K202408.

When was cobas CTNG for use on cobas 6800/8800 systems approved by the FDA?

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

What company makes cobas CTNG for use on cobas 6800/8800 systems?

cobas CTNG for use on cobas 6800/8800 systems is manufactured by Roche Molecular Systems, Inc..

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.

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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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