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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 NameCOBAS 4800 BRAF V600 MUTATION TEST
Classification Namesomatic gene mutation detection system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP110020
Supplement NumberS003
Date Received12/12/2011
Decision Date09/04/2012
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change in the dna synthesizer instrument platform for certain vialed master mix and probe reagent components.
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