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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOBAS EGFR MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantROCHE
4300 HACIENDA DRIVE
PO BOX 9002
PLEASANTON, CA 94588
PMA NumberP120019
Supplement NumberS004
Date Received12/13/2013
Decision Date03/12/2014
Product Code OWD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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