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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 IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit
Generic NameSomatic gene mutation detection system
ApplicantAbbott Molecular, Inc.
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP170005
Supplement NumberS004
Date Received03/10/2022
Decision Date04/11/2022
Product Code OWD 
Advisory Committee Molecular Genetics
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of specifications to quality control testing.
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