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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.
 
DeviceQIAGEN THERASCREEN KRAS RGQ PCR KIT
Generic NameSomatic gene mutation detection system
ApplicantQIAGEN GmbH
Qiagen Strasse 1
Hilden 40724
PMA NumberP110027
Supplement NumberS006
Date Received01/26/2015
Decision Date04/23/2015
Product Code OWD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REPLACEMENT OF LYSIS TUBE IN THE QIAAMP DSP DNA FFPE TISSUE KIT.
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