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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.
 
DeviceRealTime IDH2
Generic Namesomatic gene mutation detection system
Applicant
Abbott Molecular Inc.
1300 e. touhy avenue
des plaines, IL 60018
PMA NumberP170005
Supplement NumberS001
Date Received08/29/2019
Decision Date09/24/2019
Product Code OWD 
Advisory Committee
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional internal QC testing for the DNA Sample Preparation Kit.
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