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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 DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP110020
Supplement NumberS006
Date Received09/12/2012
Decision Date01/10/2013
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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