Tosoh Medics, Inc.: FDA clearances and approvals
Tosoh Medics, Inc. has 41 FDA 510(k) clearances (first 1990, latest 2002), across 24 product codes in 3 review panels. Median 510(k) review time: 91 days.
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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 10 | 10 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 3 | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 2 | 2 |
| DHX | System, Test, Carcinoembryonic Antigen | 2 | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 2 |
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 2 |
| CDD | Radioassay, Vitamin B12 | 1 | 1 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
Plus 14 more product codes.
Review panels
- Clinical Chemistry (26)
- Immunology (12)
- Hematology (3)
Most recent Tosoh Medics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | DHX | 2002-12-18 | 26 |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | LOJ | 2002-12-17 | 25 |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | CDZ | 2002-12-17 | 91 |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | LTK | 2002-12-06 | 14 |
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | JPD | 2002-05-14 | 90 |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | MMI | 2001-12-14 | 113 |
| K011434 | G7 AUTOMATED HPLC ANALYZER | LCP | 2001-09-18 | 131 |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | MOI | 2001-08-16 | 153 |
| K992365 | AIA-PACK FOLATE ASSAY | CGN | 1999-08-10 | 26 |
| K990431 | AIA-PACK CA 125 | LTK | 1999-06-03 | 112 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tosoh Medics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tosoh Medics, Inc. have?
Tosoh Medics, Inc. has 41 FDA 510(k) clearances (first 1990, latest 2002), across 24 product codes in 3 review panels.
How long does FDA take to clear Tosoh Medics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tosoh Medics, Inc.'s cleared 510(k)s is 91 days.
What devices does Tosoh Medics, Inc. make?
Its most frequent FDA product codes are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 10); CDP (Radioimmunoassay, Total Triiodothyronine, 3); CGN (Acid, Folic, Radioimmunoassay, 2).
Has Tosoh Medics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tosoh Medics, Inc. Related entities may recall under other names.
Next steps
- See all 41 Tosoh Medics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Tosoh Medics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.