Promega Corporation: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Promega Corporation” (first 2021, latest 2021), plus 2 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 552 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 552 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Promega Corporation took a median 552 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 552 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SFL | Nucleic Acid Based Assay, Microsatellite Instability | 2 | 0 |
| PZJ | Lynch Syndrome Test System | 1 | 1 |
Review panels
- Pathology (3)
Most recent Promega Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200129 | OncoMate MSI Dx Analysis System | PZJ | 2021-07-26 | 552 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250046 | PMA | OncoMate® MSI Dx Analysis System | 2026-09-15 |
| P240026 | PMA | OncoMate® MSI Dx Analysis System | 2025-11-05 |
Recalls
openFDA lists no recalls under a recalling firm named Promega Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Promega Corporation?
FDA lists 1 510(k) clearance under the applicant name “Promega Corporation” (first 2021, latest 2021), plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Promega Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Promega Corporation is 552 days.
Which FDA product codes appear under Promega Corporation?
The most frequent FDA product codes under this applicant name are SFL (Nucleic Acid Based Assay, Microsatellite Instability, 2); PZJ (Lynch Syndrome Test System, 1).
Next steps
- See all 1 Promega Corporation clearances with predicates and recalls
- Run predicate analysis for product code SFL, Promega Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.