PMA P160045S034

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S034
Product code: PQP
Decision date: 2022-01-21
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval of the clinical protocol titled Oncomine Dx Target Test Clinical Validation Protocol: Biomarker EGFR Exon 20 Insertions (Olympic) - PRJ0002127 Supplemental Sample Study, for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S034
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2022-01-21
Decision code: APPR
Date received: 2021-12-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the clinical protocol titled Oncomine Dx Target Test Clinical Validation Protocol: Biomarker EGFR Exon 20 Insertions (Olympic) - PRJ0002127 Supplemental Sample Study, for the post-approval study (PAS) protocol.