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. |
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Device | RealTime IDH1 |
Generic Name | Somatic gene mutation detection system |
Applicant | Abbott Molecular, Inc. 1300 East Touhy Avenue Des Plaines, IL 60018 |
PMA Number | P170041 |
Supplement Number | S001 |
Date Received | 08/29/2019 |
Decision Date | 09/24/2019 |
Product Code |
OWD |
Advisory Committee |
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Supplement Type | 30-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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