Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Dow Chemical Co. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
59 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | The Dow Chemical Co. | 1982-12-30 | 38 | 0 |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | 1982-08-05 | 13 | 0 |
| K821536 | DOWFLOW ALT-UV DETERMINATION | The Dow Chemical Co. | 1982-06-14 | 21 | 0 |
| K821315 | DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM | The Dow Chemical Co. | 1982-05-24 | 20 | 0 |
| K820675 | BILIRUBIN(TOTAL) DETERMINATION CTMS | The Dow Chemical Co. | 1982-04-01 | 21 | 0 |
| K820714 | DOW BILIRUBIN(DIRECT) DETERMINATION | The Dow Chemical Co. | 1982-04-01 | 17 | 0 |
| K812777 | DIRECT IRON REAGENT SET | The Dow Chemical Co. | 1981-10-19 | 14 | 0 |
| K811806 | QUICK-CHEM COLORIMETER | The Dow Chemical Co. | 1981-07-15 | 20 | 0 |
| K810861 | CREATINE KINASE MB ISOENZYME IMMUNO UV | The Dow Chemical Co. | 1981-04-14 | 14 | 0 |
| K810727 | AST-UV (PLP-ACTIVATED) DETERMINATION | The Dow Chemical Co. | 1981-03-31 | 14 | 0 |
| K801501 | UV URIC ACID STANDARDS | The Dow Chemical Co. | 1980-09-26 | 91 | 0 |
| K800550 | LIPASE DETERMINATION | The Dow Chemical Co. | 1980-04-02 | 23 | 0 |
| K791110 | KINETIC DETERMINATION OF UV GLUCOSE | The Dow Chemical Co. | 1979-08-03 | 50 | 0 |
| K790834 | UV URIC ACID DETERMINATION | The Dow Chemical Co. | 1979-06-28 | 59 | 0 |
| K781020 | (AST) OR (ALT) UV DETERM. PHY. PHOS. | The Dow Chemical Co. | 1978-07-27 | 42 | 0 |
| K780638 | ACCESSORY HDL CHOLESTEROL REAGENT SET | The Dow Chemical Co. | 1978-05-26 | 38 | 0 |
| K771102 | UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS | The Dow Chemical Co. | 1977-11-22 | 155 | 0 |
| K771101 | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET | The Dow Chemical Co. | 1977-07-21 | 31 | 0 |
| K770917 | GLUTAMATE OXALACETIC TRANSAMINASE | The Dow Chemical Co. | 1977-07-14 | 56 | 0 |
| K770940 | TOTAL THYROXINE (RIA) REAGENT SET | The Dow Chemical Co. | 1977-06-22 | 29 | 0 |
| K770998 | CHOLESTEROL REAGENT SET | The Dow Chemical Co. | 1977-06-02 | 0 | 0 |
| K770845 | T3 UPTAKE REAGENT SET | The Dow Chemical Co. | 1977-05-26 | 17 | 0 |
| K760672 | CLINICAL SPECTROPHOTOMETER | The Dow Chemical Co. | 1976-10-29 | 39 | 0 |
| K760010 | COLORIMETRIC DETERMINATION (SGOT/SGPT) | The Dow Chemical Co. | 1976-07-26 | 46 | 0 |
| K760011 | REAGENT, TRIGLYCERIDES | The Dow Chemical Co. | 1976-07-26 | 46 | 0 |
| K760009 | COLORIMETRIC DETERMINATION (LDH) | The Dow Chemical Co. | 1976-07-20 | 40 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda