PMA
P200011: ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
FDA PMA · Next generation sequencing oncology panel, somatic or germline variant detection system · Pillar Biosciences
Key facts
| PMA number | P200011 |
|---|---|
| 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 |
| Owner/operator | Pillar Biosciences |
| Product code | PQP |
| Approval date | Jul 30, 2021 |
| Docket number | 21M-0853 |
| Notice date | Aug 3, 2021 |
| Establishment registration | 3020703032 |
| FEI number | 3016560486 |
At a glance
- 1–9 Supplements
- Sep 27, 2024 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: