PMA P240040S002

Device: Oncomine Dx Express Test
Applicant: Life Technologies Corporation
PMA number: P240040
Supplement: S002
Product code: PQP
Decision date: 2025-10-15
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval of the non-clinical Post-Approval Study (PAS) protocol for precision and sample equivalency studies using core needle biopsy and fine needle aspirate samples (PCP0141593).

Current openFDA PMA Record#

Device: Oncomine Dx Express Test
Applicant: Life Technologies Corporation
PMA number: P240040
Supplement: S002
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-10-15
Decision code: APPR
Date received: 2025-08-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the non-clinical Post-Approval Study (PAS) protocol for precision and sample equivalency studies using core needle biopsy and fine needle aspirate samples (PCP0141593).