Worthington Diagnostic Systems: FDA clearances and approvals
Worthington Diagnostic Systems has 19 FDA 510(k) clearances (first 1979, latest 1984), across 17 product codes in 3 review panels. Median 510(k) review time: 42 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 |
|---|---|---|---|
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| CIJ | Saccharogenic, Amylase | 1 | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 | 1 |
Plus 7 more product codes.
Review panels
- Clinical Chemistry (12)
- Hematology (4)
- Immunology (3)
Most recent Worthington Diagnostic Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | LKZ | 1984-01-04 | 76 |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | KNK | 1983-10-14 | 59 |
| K832749 | EASYTOUCH BUN REAGENT SET | CDQ | 1983-10-14 | 60 |
| K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN | CIG | 1983-10-14 | 60 |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | GJS | 1983-10-14 | 84 |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | KHG | 1983-09-26 | 42 |
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | CDT | 1983-09-12 | 52 |
| K831477 | DEMAND ANALYZER SYSTEM | JJE | 1983-06-17 | 39 |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | JPI | 1983-06-08 | 47 |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | JJF | 1983-06-02 | 48 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Worthington Diagnostic Systems.
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 Diagnostic Systems have?
Worthington Diagnostic Systems has 19 FDA 510(k) clearances (first 1979, latest 1984), across 17 product codes in 3 review panels.
How long does FDA take to clear Worthington Diagnostic Systems's 510(k)s?
The median time from FDA receipt to decision across Worthington Diagnostic Systems's cleared 510(k)s is 42 days.
What devices does Worthington Diagnostic Systems make?
Its most frequent FDA product codes are JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes, 2); KNK (Acid, Uric, Uricase (Colorimetric), 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1).
Has Worthington Diagnostic Systems had device recalls?
openFDA lists no recalls under a recalling firm name matching Worthington Diagnostic Systems. Related entities may recall under other names.
Next steps
- See all 19 Worthington Diagnostic Systems clearances with predicates and recalls
- Run predicate analysis for product code JHS, Worthington Diagnostic Systems'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.