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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 4800 BRAF V600 MUTATION TEST
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP110020
Supplement NumberS001
Date Received09/19/2011
Decision Date10/17/2011
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 Yes
Approval Order Statement 
ADDITIONAL OF FUNCTIONAL TESTING AT THE FINAL VIAL STAGE IN THE MANUFACTURE OF THE DEVICE MUTATION POSITIVE CONTROL (MU) AND THE WILD-TYPE CONTROL (WT).
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