PMA P160045S030
- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S030
- Product code
- PQP
- Decision date
- 2021-06-11
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Move the work-in-process and raw materials used in the manufacturing to a new storage location.
Current openFDA PMA Record#
- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S030
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2021-06-11
- Decision code
- OK30
- Date received
- 2021-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the work-in-process and raw materials used in the manufacturing to a new storage location.