The Dow Chemical Co.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “The Dow Chemical Co.” (first 1976, latest 1982), across 19 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| 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 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Dow Chemical Co.?
FDA lists 26 510(k) clearances under the applicant name “The Dow Chemical Co.” (first 1976, latest 1982), across 19 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 The Dow Chemical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Dow Chemical Co. is 30 days.
Which FDA product codes appear under The Dow Chemical Co.?
The most frequent FDA product codes under this applicant name are CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot, 3); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2).
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. 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.