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 | Guardant360 CDx |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Guardant Health, Inc. 505 Penobscot Drive Redwood City, CA 94063 |
PMA Number | P200010 |
Supplement Number | S005 |
Date Received | 12/17/2021 |
Decision Date | 03/16/2022 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to use reagent lots interchangeably for Guardant360 CDx Sample Preparation Kit Boxes and a minor software update to accommodate the reagent interchangeability update. |
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