PMA P160045S001
- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S001
- Product code
- PQP
- Decision date
- 2017-08-14
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Change to the storage location for raw and WIP (work in-process) materials used in the manufacture of the Oncomine Dx Target Test device.
Current openFDA PMA Record#
- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S001
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2017-08-14
- Decision code
- OK30
- Date received
- 2017-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the storage location for raw and WIP (work in-process) materials used in the manufacture of the Oncomine Dx Target Test device.