Tosoh Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Tosoh Corp.” (first 1990, latest 2002), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | 2 | 2 |
| NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
Review panels
- Clinical Chemistry (9)
- Immunology (2)
Most recent Tosoh Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023240 | ST AIA-PACK CA 19-9 | NIG | 2002-12-23 | 87 |
| K023239 | AIA-PACK CA 19-9 | NIG | 2002-12-23 | 87 |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | 1992-07-21 | 28 |
| K913663 | AIA-PACK T-U | KHQ | 1991-09-30 | 45 |
| K913298 | AIA-PACK CK-MB | JHX | 1991-09-27 | 64 |
| K913493 | AIA-PACK FT4 | CEC | 1991-09-10 | 35 |
| K903628 | AIA-PACK IRI | CFP | 1990-09-07 | 28 |
| K901965 | MPR-4A - MICRO-PLATE READER | JJQ | 1990-05-10 | 10 |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | KHO | 1990-05-02 | 22 |
| K897001 | TOSOH AIA-PACK T3 | CDP | 1990-03-09 | 81 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tosoh Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tosoh Medics, Inc. (41 510(k)s)
- Tosoh Bioscience, Inc. (20 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tosoh Corp.?
FDA lists 11 510(k) clearances under the applicant name “Tosoh Corp.” (first 1990, latest 2002), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tosoh Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tosoh Corp. is 45 days.
Which FDA product codes appear under Tosoh Corp.?
The most frequent FDA product codes under this applicant name are KHO (Fluorometer, For Clinical Use, 2); NIG (System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer, 2); CDP (Radioimmunoassay, Total Triiodothyronine, 1).
Next steps
- See all 11 Tosoh Corp. clearances with predicates and recalls
- Run predicate analysis for product code KHO, Tosoh Corp.'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.