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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 NumberS004
Date Received09/20/2012
Decision Date11/19/2012
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the cpu component of the cobas z480 analyzer.
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