PMA P200011
- Device
- ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
- Applicant
- Pillar Biosciences
- PMA number
- P200011
- Product code
- PQP
- Decision date
- 2024-09-27
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- APPR
Current openFDA PMA Record#
- Device
- ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
- Applicant
- Pillar Biosciences
- PMA number
- P200011
- Supplement
- S002
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2024-09-27
- Decision code
- APPR
- Date received
- 2024-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPR