Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

49 results for "Roche Molecular Systems, Inc."
25–48 of 49
Cleared Feb 10, 2020
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas...
K200065 · OCC
Roche Molecular Systems, Inc.
Microbiology · 28d
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016 · QIV
Roche Molecular Systems, Inc.
Microbiology · 261d
Cleared Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729 · OCC
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared May 22, 2019
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control...
K190433 · QEP
Roche Molecular Systems, Inc.
Microbiology · 89d
Cleared Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Jan 12, 2018
cobas Factor II and Factor V Test
K172913 · NPR
Roche Molecular Systems, Inc.
Hematology · 109d
Cleared Sep 12, 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · OZN
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Feb 09, 2017
cobas® CT/NG v2.0 Test
K163184 · LSL
Roche Molecular Systems, Inc.
Microbiology · 87d
Cleared Jun 01, 2015
cobas HSV 1 and 2 Test
K150617 · OQO
Roche Molecular Systems, Inc.
Microbiology · 83d
Cleared May 20, 2015
cobas Cdiff Test
K142422 · OZN
Roche Molecular Systems, Inc.
Microbiology · 265d
Cleared Dec 17, 2014
cobas MRSA/SA Test
K142721 · NQX
Roche Molecular Systems, Inc.
Microbiology · 85d
Cleared May 05, 2014
COBAS CT/NG V2.0 TEST
K140887 · LSL
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Dec 02, 2013
COBAS CT/NG V2.0 TEST
K132270 · LSL
Roche Molecular Systems, Inc.
Microbiology · 133d
Cleared Jan 24, 2012
COBAS 4800 CT / NG TEST
K110923 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 298d
Cleared Jul 06, 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT,...
K091409 · NQX
Roche Molecular Systems, Inc.
Microbiology · 419d
Cleared Jan 10, 2005
ROCHE AMPLICHIP CYP450 TEST
K043576 · NTI
Roche Molecular Systems, Inc.
Chemistry · 14d
Not Cleared Dec 23, 2004
AMPLICHIP CYP450 TEST, MODEL 04381866190
DEN040011 · NTI
Roche Molecular Systems, Inc.
Chemistry · 3d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966 · JJF
Roche Molecular Systems, Inc.
Chemistry · 150d
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · LSL
Roche Molecular Systems, Inc.
Microbiology · 733d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 674d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342 · LSL
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 442d
Cleared Jun 13, 1997
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K964507 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 217d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506 · JJF
Roche Molecular Systems, Inc.
Chemistry · 194d