Data / Medical devices / United States / Pillar Biosciences
Pillar Biosciences: FDA-registered device maker in Natick, MA, United States, 1 PMA approval
Pillar Biosciences is registered with the FDA (registration 3020703032) in Natick, MA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated July 30, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020703032
- FEI number
- 3016560486
- Address
- 9 Strathmore Road, Natick, MA, United States, 01760
- Owner or operator
- Pillar Biosciences (10082584)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 19, 2021
- Registered through
- 2026
- Brand names listed
- PiVAT Software, oncoReveal CDx, oncoReveal CDx Box 1, oncoReveal CDx Box 2, oncoReveal CDx Box 3, oncoReveal CDx Box 4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 30, 2021 | P200011 | ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) | PQP | 2 | September 27, 2024 | accessdata.fda.gov |
Compare with other makers
Updated September 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.