Asuragen, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Asuragen, Inc.” (first 2012, latest 2012), plus 2 De Novo decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 119 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 |
|---|---|---|
| 2012 | 1 | 119 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OYV | Inherited Nucleotide Repeat Disorder Dna Test | 1 | 0 |
| OYX | Bcr/Abl1 Monitoring Test | 1 | 0 |
| OZF | Tissue Rna Preservative For Collection, Storage, And Transportation | 1 | 1 |
Review panels
- Pathology (3)
Most recent Asuragen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113420 | RNARETAIN | OZF | 2012-03-16 | 119 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190023 | De Novo | Inherited Nucleotide Repeat Disorder Dna Test | 2020-02-21 |
| DEN160003 | De Novo | Bcr/Abl1 Monitoring Test | 2016-07-22 |
Recalls
openFDA lists no recalls under a recalling firm named Asuragen, Inc..
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 Asuragen, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Asuragen, Inc.” (first 2012, latest 2012), plus 2 De Novo decisions, across 3 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 Asuragen, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Asuragen, Inc. is 119 days.
Which FDA product codes appear under Asuragen, Inc.?
The most frequent FDA product codes under this applicant name are OYV (Inherited Nucleotide Repeat Disorder Dna Test, 1); OYX (Bcr/Abl1 Monitoring Test, 1); OZF (Tissue Rna Preservative For Collection, Storage, And Transportation, 1).
Next steps
- See all 1 Asuragen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OYV, Asuragen, Inc.'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.