FDA 510(k) Applications Submitted by Roche Molecular Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K243863 12/17/2024 OpulusÖ Lymphoma Precision Roche Molecular Systems, Inc.
K973718 09/29/1997 ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE MOLECULAR SYSTEMS, INC.
K973707 09/29/1997 ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS ROCHE MOLECULAR SYSTEMS, INC.
K964507 11/08/1996 ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST ROCHE MOLECULAR SYSTEMS, INC.
K964506 11/08/1996 ROCHE COBAS AMPLICOR ANALYZER ROCHE MOLECULAR SYSTEMS, INC.
K974342 11/18/1997 ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC.
K974503 11/28/1997 ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE MOLECULAR SYSTEMS, INC.
K202408 08/21/2020 cobas CTNG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc.
K223591 12/01/2022 cobas« SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas« Liat« System Roche Molecular Systems, Inc.
K223783 12/16/2022 cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K221007 04/05/2022 cobas HCV Roche Molecular Systems, Inc.
K231306 05/05/2023 cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems Roche Molecular Systems, Inc.
K171770 06/14/2017 cobas Cdiff Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K150617 03/10/2015 cobas HSV 1 and 2 Test ROCHE MOLECULAR SYSTEMS, INC.
K163184 11/14/2016 cobas« CT/NG v2.0 Test Roche Molecular Systems, Inc.
K240197 01/25/2024 cobas« liat CT/NG/MG nucleic acid test Roche Molecular Systems, Inc.
K240217 01/26/2024 cobas« liat CT/NG nucleic acid test Roche Molecular Systems, Inc.
K243346 10/28/2024 cobas liat SARS-CoV-2 v2 nucleic acid test Roche Molecular Systems, Inc.
K210385 02/09/2021 cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K012966 09/04/2001 ROCHE COBAS TAQMAN ANALYZER ROCHE MOLECULAR SYSTEMS, INC.
K110923 04/01/2011 COBAS 4800 CT / NG TEST ROCHE MOLECULAR SYSTEMS, INC.
DEN040011 12/20/2004 AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC.
K043576 12/27/2004 ROCHE AMPLICHIP CYP450 TEST ROCHE MOLECULAR SYSTEMS, INC.
K200065 01/13/2020 cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K210234 01/28/2021 cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K191729 06/27/2019 Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System Roche Molecular Systems, Inc.
K212427 08/04/2021 cobas Cdiff nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K213822 12/08/2021 cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc.
K091409 05/13/2009 LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 ROCHE MOLECULAR SYSTEMS, INC.
K240867 03/29/2024 cobas« SARS-CoV-2 Qualitative for use on the cobas« 5800/6800/8800 Systems Roche Molecular Systems, Inc.
K190433 02/22/2019 cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc.
DEN190016 03/19/2019 cobas vivoDx MRSA Roche Molecular Systems, Inc.
K173887 12/21/2017 cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc.
K172913 09/25/2017 cobas Factor II and Factor V Test Roche Molecular Systems, Inc.
K203220 11/02/2020 cobas BKV Roche Molecular Systems, Inc.
DEN200015 03/02/2020 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc.
K202215 08/06/2020 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc.
K213804 12/06/2021 cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems Roche Molecular Systems, Inc.
K243400 10/31/2024 cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test Roche Molecular Systems, Inc.
K243406 11/01/2024 cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test Roche Molecular Systems, Inc.
K132270 07/22/2013 COBAS CT/NG V2.0 TEST ROCHE MOLECULAR SYSTEMS, INC.
K140887 04/07/2014 COBAS CT/NG V2.0 TEST ROCHE MOLECULAR SYSTEMS, INC.
K142422 08/28/2014 cobas Cdiff Test ROCHE MOLECULAR SYSTEMS, INC.
K142721 09/23/2014 cobas MRSA/SA Test ROCHE MOLECULAR SYSTEMS, INC.


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