ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
FDA premarket approval P200011/S002 · decided 2024-09-27
Approval details
- PMA number
- P200011
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Pillar Biosciences
- Date received
- 2024-07-23
- Decision date
- 2024-09-27
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Natick, MA
- Statement
- APPR
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