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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameROCHE COBAS 4800 BRAF V600 MUTATION TEST
Classification Namesomatic gene mutation detection system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP110020
Supplement NumberS001
Date Received09/20/2011
Decision Date10/17/2011
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
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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