The Dow Chemical Co.
Walker, MI, US
The Dow Chemical Co. appears in FDA device records in Walker, MI. FDA records list 26 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for The Dow Chemical Co. between 1976 and 1982. The busiest year on record is 1977, with 6. The most recent is 1982, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 6 |
| 1978 | 2 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 4 |
| 1982 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | CGA | Substantially Equivalent | |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | CDN | Substantially Equivalent | |
| K821536 | DOWFLOW ALT-UV DETERMINATION | CKA | Substantially Equivalent | |
| K821315 | DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM | CDT | Substantially Equivalent | |
| K820714 | DOW BILIRUBIN(DIRECT) DETERMINATION | CIG | Substantially Equivalent | |
| K820675 | BILIRUBIN(TOTAL) DETERMINATION CTMS | CIG | Substantially Equivalent | |
| K812777 | DIRECT IRON REAGENT SET | JIY | Substantially Equivalent | |
| K811806 | QUICK-CHEM COLORIMETER | JJQ | Substantially Equivalent | |
| K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV | JHW | Substantially Equivalent | |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | CIT | Substantially Equivalent | |
| K801501 | UV URIC ACID STANDARDS | JIS | Substantially Equivalent | |
| K800550 | LIPASE DETERMINATION | CFG | Substantially Equivalent | |
| K791110 | KINETIC DETERMINATION OF UV GLUCOSE | LFR | Substantially Equivalent | |
| K790834 | UV URIC ACID DETERMINATION | CDO | Substantially Equivalent | |
| K781020 | (AST) OR (ALT) UV DETERM. PHY. PHOS. | CIT | Substantially Equivalent | |
| K780638 | ACCESSORY HDL CHOLESTEROL REAGENT SET | CHH | Substantially Equivalent | |
| K771102 | UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS | LFR | Substantially Equivalent | |
| K771101 | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET | GIG | Substantially Equivalent | |
| K770917 | GLUTAMATE OXALACETIC TRANSAMINASE | Substantially Equivalent | ||
| K770940 | TOTAL THYROXINE (RIA) REAGENT SET | CDX | Substantially Equivalent | |
| K770998 | CHOLESTEROL REAGENT SET | CHH | Substantially Equivalent | |
| K770845 | T3 UPTAKE REAGENT SET | KHQ | Substantially Equivalent | |
| K760672 | CLINICAL SPECTROPHOTOMETER | JJQ | Substantially Equivalent | |
| K760011 | REAGENT, TRIGLYCERIDES | CDT | Substantially Equivalent | |
| K760010 | COLORIMETRIC DETERMINATION (SGOT/SGPT) | CIT | Substantially Equivalent | |
| K760009 | COLORIMETRIC DETERMINATION (LDH) | CFH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDOAcid, Uric, Uricase (U.V.)
- JISCalibrator, Primary
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- GIGHemoglobinometer
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CFGOil Emulsion/Thymolphthalein (Titrimetric), Lipase
- JIYPhotometric Method, Iron (Non-Heme)
- KHQRadioassay, Triiodothyronine Uptake
- CDXRadioimmunoassay, Total Thyroxine
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- JHWU.V. Method, Cpk Isoenzymes
- CDNUrease, Photometric, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain