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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.
 
DeviceAbbott RealTime IDH1
Generic NameSomatic gene mutation detection system
ApplicantAbbott Molecular, Inc.
1300 East Touhy Avenue
Des Plaines, IL 60018
PMA NumberP170041
Supplement NumberS004
Date Received01/06/2021
Decision Date06/02/2022
Product Code OWD 
Advisory Committee
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the labeling changes that integrate the data obtained from the non-clinical Condition of Appoval (CoA) study of eluate reproducibility.
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