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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOBAS EGFR MUTATION TEST
Classification Namesomatic gene mutation detection system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP120019
Supplement NumberS004
Date Received12/13/2013
Decision Date03/12/2014
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the cobas 4800 sr2 system software architecture and assay specific analysis package (asap) software for the cobas braf v600 mutation test and cobas egfr mutation test.
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