PMA P160045S024
- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S024
- Product code
- PQP
- Decision date
- 2020-12-01
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- manufacturing process and material changes
Current openFDA PMA Record#
- Device
- Oncomine Dx Target Test
- Applicant
- Life Technologies Corporation
- PMA number
- P160045
- Supplement
- S024
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2020-12-01
- Decision code
- OK30
- Date received
- 2020-11-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing process and material changes