The Dow Chemical Co.: FDA clearances and approvals
The Dow Chemical Co. has 26 FDA 510(k) clearances (first 1976, latest 1982), across 19 product codes in 2 review panels. Median 510(k) review time: 30 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 |
|---|---|---|---|
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| LFR | Glucose Dehydrogenase, Glucose | 2 | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CFG | Oil Emulsion/Thymolphthalein (Titrimetric), Lipase | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (24)
- Hematology (1)
Most recent The Dow Chemical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | CGA | 1982-12-30 | 38 |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | CDN | 1982-08-05 | 13 |
| K821536 | DOWFLOW ALT-UV DETERMINATION | CKA | 1982-06-14 | 21 |
| K821315 | DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM | CDT | 1982-05-24 | 20 |
| K820714 | DOW BILIRUBIN(DIRECT) DETERMINATION | CIG | 1982-04-01 | 17 |
| K820675 | BILIRUBIN(TOTAL) DETERMINATION CTMS | CIG | 1982-04-01 | 21 |
| K812777 | DIRECT IRON REAGENT SET | JIY | 1981-10-19 | 14 |
| K811806 | QUICK-CHEM COLORIMETER | JJQ | 1981-07-15 | 20 |
| K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV | JHW | 1981-04-14 | 14 |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | CIT | 1981-03-31 | 14 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Dow Chemical Co..
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 The Dow Chemical Co. have?
The Dow Chemical Co. has 26 FDA 510(k) clearances (first 1976, latest 1982), across 19 product codes in 2 review panels.
How long does FDA take to clear The Dow Chemical Co.'s 510(k)s?
The median time from FDA receipt to decision across The Dow Chemical Co.'s cleared 510(k)s is 30 days.
What devices does The Dow Chemical Co. make?
Its most frequent FDA product codes are CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 3); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2).
Has The Dow Chemical Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Dow Chemical Co. Related entities may recall under other names.
Next steps
- See all 26 The Dow Chemical Co. clearances with predicates and recalls
- Run predicate analysis for product code CIT, The Dow Chemical Co.'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.