PMA P160045S038

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S038
Product code: PQP
Decision date: 2023-02-01
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to update the user guide for the Oncomine Dx Target Test to include the results of the supplemental clinical data submitted in the Post-Approval Study (PAS) Protocol.

Current openFDA PMA Record#

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S038
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2023-02-01
Decision code: APPR
Date received: 2022-08-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval to update the user guide for the Oncomine Dx Target Test to include the results of the supplemental clinical data submitted in the Post-Approval Study (PAS) Protocol.