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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 EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
ROCHE
4300 hacienda drive
po box 9002
pleasanton, CA 94588
PMA NumberP120019
Supplement NumberS015
Date Received09/26/2017
Decision Date10/13/2017
Product Code
OWD[ Registered Establishments with 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 
Use larger columns for purification steps in probe manufacturing.
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