Wako Pure Chemical Industries, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Wako Pure Chemical Industries, Ltd.” (first 1979, latest 1984), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CEL | Ammonium Molybdate And Ammonium Vanadate, Phospholipids | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JID | Photometric Method, Ammonia | 1 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 1 |
Review panels
Most recent Wako Pure Chemical Industries, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842221 | WAKO GLUCOSE C | CGA | 1984-07-12 | 37 |
| K813366 | AMMONIA TEST | JID | 1981-12-22 | 22 |
| K801891 | WAKO TRIGLYCERIDE-G TEST | CDT | 1980-09-16 | 39 |
| K801834 | WAKO HDL CHOLESTEROL TEST | LBS | 1980-09-16 | 46 |
| K801076 | WAKO PHOSPHOLIPIDS TEST | CEL | 1980-06-30 | 54 |
| K791597 | WAKO TRIGLYCERIDE | CDT | 1979-09-17 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Wako Pure Chemical Industries, Ltd..
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.
- Wako Chemicals USA, Inc. (123 510(k)s)
- Wako Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wako Pure Chemical Industries, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Wako Pure Chemical Industries, Ltd.” (first 1979, latest 1984), across 5 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 Wako Pure Chemical Industries, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wako Pure Chemical Industries, Ltd. is 38 days.
Which FDA product codes appear under Wako Pure Chemical Industries, Ltd.?
The most frequent FDA product codes under this applicant name are CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CEL (Ammonium Molybdate And Ammonium Vanadate, Phospholipids, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 6 Wako Pure Chemical Industries, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CDT, Wako Pure Chemical Industries, Ltd.'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.