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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 KIT
Generic Namesomatic gene mutation detection system
ApplicantbioMerieux, Inc.
595 anglum rd.
hazelwood, MO 63042
PMA NumberP120014
Supplement NumberS003
Date Received02/24/2015
Decision Date05/27/2015
Product Code OWD 
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USING THE UPDATED ABI 7500 FAST DX OPERATING SYSTEM AND SDS SOFTWARE.
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