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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 KRAS Mutation Test
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP140023
Supplement NumberS020
Date Received04/24/2019
Decision Date05/22/2019
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in manufacturing gowning procedures.
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