Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices

Not Cleared Dec 05, 2019

cobas vivoDx MRSA

DEN190016 · QIV

Microbiology · 261d

Cleared Jul 24, 2019

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

K191729 · OCC

Microbiology · 27d

Cleared May 22, 2019

cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control...

K190433 · QEP

Microbiology · 89d

Cleared Mar 21, 2018

cobas CT/NG for use on cobas 6800/8800 systems

K173887 · LSL

Microbiology · 90d

Cleared Jan 12, 2018

cobas Factor II and Factor V Test

K172913 · NPR

Hematology · 109d

Cleared Sep 12, 2017

cobas Cdiff Nucleic acid test for use on the cobas Liat System

K171770 · OZN

Microbiology · 90d

Cleared Feb 09, 2017

cobas® CT/NG v2.0 Test

K163184 · LSL

Microbiology · 87d

Cleared Jun 01, 2015

cobas HSV 1 and 2 Test

K150617 · OQO

Microbiology · 83d

Cleared May 20, 2015

cobas Cdiff Test

K142422 · OZN

Microbiology · 265d

Cleared Dec 17, 2014

cobas MRSA/SA Test

K142721 · NQX

Microbiology · 85d

Cleared May 05, 2014

COBAS CT/NG V2.0 TEST

K140887 · LSL

Microbiology · 28d

Cleared Dec 02, 2013

COBAS CT/NG V2.0 TEST

K132270 · LSL

Microbiology · 133d

Cleared Jan 24, 2012

COBAS 4800 CT / NG TEST

K110923 · MKZ

Microbiology · 298d

Cleared Jul 06, 2010

LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT,...

K091409 · NQX

Microbiology · 419d

Cleared Jan 10, 2005

ROCHE AMPLICHIP CYP450 TEST

K043576 · NTI

Chemistry · 14d

Not Cleared Dec 23, 2004

AMPLICHIP CYP450 TEST, MODEL 04381866190

DEN040011 · NTI

Chemistry · 3d

Cleared Feb 01, 2002

ROCHE COBAS TAQMAN ANALYZER

K012966 · JJF

Chemistry · 150d

Cleared Dec 01, 1999

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K974503 · LSL

Microbiology · 733d

Cleared Aug 04, 1999

ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

K973707 · MKZ

Microbiology · 674d

Cleared May 28, 1999

ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

K974342 · LSL

Microbiology · 556d

Cleared Dec 15, 1998

ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

K973718 · MKZ

Microbiology · 442d

Cleared Jun 13, 1997

ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST

K964507 · MKZ

Microbiology · 217d

Cleared May 21, 1997

ROCHE COBAS AMPLICOR ANALYZER

K964506 · JJF

Chemistry · 194d

Cleared Jun 15, 1993

AMPLICOR CHLAMYDIA TRACHOMATIS TEST

K922906 · MKZ

Microbiology · 363d