PMA P240010

Device
MI Cancer SeekĀ®
Applicant
Caris Life Sciences
Product code
PQP
Decision date
2026-05-28
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Manufacturing process change.

Current openFDA PMA Record#

Device
MI Cancer SeekĀ®
Applicant
Caris Life Sciences
PMA number
P240010
Supplement
S009
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2026-05-28
Decision code
OK30
Date received
2026-04-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing process change.