Tm Bioscience Corporation: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Tm Bioscience Corporation” (first 2006, latest 2006), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 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 | 0 | — |
| 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 |
|---|---|---|---|
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 2 | 1 |
Review panels
- Pathology (2)
Most recent Tm Bioscience Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060627 | TAG-IT CYSTIC FIBROSIS KIT | NUA | 2006-06-07 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN050004 | De Novo | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 2005-05-09 |
Recalls
openFDA lists no recalls under a recalling firm named Tm Bioscience 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 Tm Bioscience Corporation?
FDA lists 1 510(k) clearance under the applicant name “Tm Bioscience Corporation” (first 2006, latest 2006), plus 1 De Novo decision, across 1 product code 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 Tm Bioscience Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tm Bioscience Corporation is 90 days.
Which FDA product codes appear under Tm Bioscience Corporation?
The most frequent FDA product codes under this applicant name are NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, 2).
Next steps
- See all 1 Tm Bioscience Corporation clearances with predicates and recalls
- Run predicate analysis for product code NUA, Tm Bioscience 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.