cobas CT/NG for use on cobas 6800/8800 systems
K-Number: K173887 · 2018-03-21
ApplicantRoche Molecular Systems, Inc.
Decision Date2018-03-21
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
cobas CT/NG for use on cobas 6800/8800 systems is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2018-03-21 under approval number K173887. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the cobas CT/NG for use on cobas 6800/8800 systems?
cobas CT/NG for use on cobas 6800/8800 systems is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K173887.
When was cobas CT/NG for use on cobas 6800/8800 systems approved by the FDA?
cobas CT/NG for use on cobas 6800/8800 systems received FDA 510(k) clearance on 2018-03-21, under approval number K173887.
What company makes cobas CT/NG for use on cobas 6800/8800 systems?
cobas CT/NG for use on cobas 6800/8800 systems is manufactured by Roche Molecular Systems, Inc..
What is the FDA product code for cobas CT/NG for use on cobas 6800/8800 systems?
The FDA product code for cobas CT/NG for use on cobas 6800/8800 systems is LSL.
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Related Devices (Code: LSL)
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.