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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 DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190
Classification Namesomatic gene mutation detection system
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP110020
Supplement NumberS006
Date Received09/13/2012
Decision Date01/10/2013
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of poly ra to the braf mutant and wild-type controls buffer matrix and associated manufacturing process changes.
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