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 | LeukoStrat CDx FLT3 Mutation Assay |
Generic Name | Somatic gene mutation detection system |
Applicant | INVIVOSCRIBE TECHNOLOGIES, INC 10222 Barnes Canyon Road, Building 1 San Diego, CA 92121 |
PMA Number | P160040 |
Supplement Number | S009 |
Date Received | 07/12/2021 |
Decision Date | 08/11/2021 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Qualification of an automated process for fill, finish, and label the kit components. |
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