Wako Chemicals USA, Inc.: FDA clearances and approvals
Wako Chemicals USA, Inc. has 123 FDA 510(k) clearances (first 1981, latest 2011), plus 1 De Novo decision, across 59 product codes in 4 review panels. Median 510(k) review time: 52 days. openFDA lists 3 product recalls by a recalling firm named Wako Chemicals USA, Inc.
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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | 15 | 15 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 9 | 9 |
| JIS | Calibrator, Primary | 7 | 7 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 | 4 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 4 | 4 |
| CEK | Biuret (Colorimetric), Total Protein | 3 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 | 3 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 3 |
Plus 49 more product codes.
Review panels
- Clinical Chemistry (91)
- Immunology (30)
- Hematology (1)
- Pathology (1)
Most recent Wako Chemicals USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | NSF | 2011-02-23 | 370 |
| K080125 | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 | LBS | 2008-07-18 | 183 |
| K080123 | APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 | CFR | 2008-07-17 | 182 |
| K061775 | WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR | JFY | 2007-02-23 | 245 |
| K062368 | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 | OAU | 2007-01-31 | 170 |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 | JFM | 2005-12-30 | 52 |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 | JFM | 2005-12-30 | 52 |
| K042551 | MULTI-CHEM CALIBRATOR A | JIX | 2004-11-16 | 57 |
| K042550 | MULTI-LIPID CALIBRATOR | JIX | 2004-11-08 | 49 |
| K042549 | MULTI CHEM CAL B | JIX | 2004-11-08 | 49 |
113 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN050002 | De Novo | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 2005-05-19 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2012-01-30.
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 Wako Chemicals USA, Inc. have?
Wako Chemicals USA, Inc. has 123 FDA 510(k) clearances (first 1981, latest 2011), plus 1 De Novo decision, across 59 product codes in 4 review panels.
How long does FDA take to clear Wako Chemicals USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Wako Chemicals USA, Inc.'s cleared 510(k)s is 52 days.
What devices does Wako Chemicals USA, Inc. make?
Its most frequent FDA product codes are JIT (Calibrator, Secondary, 15); DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control, 9); JIS (Calibrator, Primary, 7).
Has Wako Chemicals USA, Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Wako Chemicals USA, Inc; the most recent began 2012-01-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 123 Wako Chemicals USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIT, Wako Chemicals USA, 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.