cobas® CT/NG v2.0 Test
K-Number: K163184 · 2017-02-09
ApplicantRoche Molecular Systems, Inc.
Decision Date2017-02-09
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
cobas® CT/NG v2.0 Test is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2017-02-09 under approval number K163184. 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 v2.0 Test?
cobas® CT/NG v2.0 Test is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K163184.
When was cobas® CT/NG v2.0 Test approved by the FDA?
cobas® CT/NG v2.0 Test received FDA 510(k) clearance on 2017-02-09, under approval number K163184.
What company makes cobas® CT/NG v2.0 Test?
cobas® CT/NG v2.0 Test is manufactured by Roche Molecular Systems, Inc..
What is the FDA product code for cobas® CT/NG v2.0 Test?
The FDA product code for cobas® CT/NG v2.0 Test is LSL.
Other Devices by Roche Molecular Systems, Inc.
K171770cobas Cdiff Nucleic acid test for use on the cobas Liat System
K173887cobas CT/NG for use on cobas 6800/8800 systems
K172913cobas Factor II and Factor V Test
DEN190016cobas vivoDx MRSA
K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
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.