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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.
 
DeviceROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP140023
Supplement NumberS002
Date Received09/02/2015
Decision Date09/24/2015
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL OF GE HEALTHCARE SOURCED MATERIAL MANUFACTURED AT THE THERMOFISHER SCIENTIFIC FACILITY LOCATED IN VILNIUS, LITHUANIA AS AN APPROVED SUPPLIER OF POLYADENYLIC ACID POLYMER, POTASSIUM SALT (POLY A) FOR THE ROCHE MOLECULAR SYSTEMS FACILITY IN BRANCHBURG, NEW JERSEY.
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