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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, ROCHE COBAS 4800 BRAF V600 MUTATION TEST
Generic NameSomatic gene mutation detection system
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Dr.
Pleasanton, CA 94588
PMA NumberP110020
Supplement NumberS014
Date Received06/24/2015
Decision Date07/23/2015
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
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