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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.
 
DeviceTHxID BRAF assay kit
Generic Namesomatic gene mutation detection system
ApplicantbioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP120014
Supplement NumberS009
Date Received08/07/2019
Decision Date08/26/2019
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Manufacturing site change for a raw material (critical component).
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