Worthington Biochemical Corp.: FDA clearances and approvals
Worthington Biochemical Corp. has 13 FDA 510(k) clearances (first 1976, latest 1978), across 10 product codes in 1 review panel. Median 510(k) review time: 28 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 |
|---|---|---|---|
| CDO | Acid, Uric, Uricase (U.V.) | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| JIS | Calibrator, Primary | 1 | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 1 |
Review panels
- Clinical Chemistry (13)
Most recent Worthington Biochemical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K780389 | HDL REAGENT SET FOR LIPOPROTEINS | CHH | 1978-04-19 | 40 |
| K780096 | LDH ISOENZYME CONTROL SERUM | JJY | 1978-03-03 | 44 |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | CEX | 1978-01-24 | 28 |
| K772025 | URIC ACID STD. FOR QUANT. URIC ACID | JIS | 1977-11-11 | 15 |
| K771143 | INORGANIC PHOSPHORUS STANDARDS | JIT | 1977-07-11 | 14 |
| K771001 | STATZYME GLUCOSE | CGA | 1977-07-11 | 38 |
| K770831 | STATZYME URIC ACID REAGENT | CDO | 1977-07-11 | 66 |
| K770470 | WORTHINGTON BUN | CDW | 1977-06-02 | 84 |
| K770277 | CHOLESTEROL STANDARDS | JIT | 1977-03-01 | 15 |
| K761263 | CHOLESTEROL AUTOMATED REAGENT | CHH | 1976-12-29 | 13 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Worthington Biochemical Corp..
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 Worthington Biochemical Corp. have?
Worthington Biochemical Corp. has 13 FDA 510(k) clearances (first 1976, latest 1978), across 10 product codes in 1 review panel.
How long does FDA take to clear Worthington Biochemical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Worthington Biochemical Corp.'s cleared 510(k)s is 28 days.
What devices does Worthington Biochemical Corp. make?
Its most frequent FDA product codes are CDO (Acid, Uric, Uricase (U.V.), 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2); JIT (Calibrator, Secondary, 2).
Has Worthington Biochemical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Worthington Biochemical Corp. Related entities may recall under other names.
Next steps
- See all 13 Worthington Biochemical Corp. clearances with predicates and recalls
- Run predicate analysis for product code CDO, Worthington Biochemical Corp.'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.