Worthington Diagnostic Systems
Mchenry, IL, US
Worthington Diagnostic Systems appears in FDA device records in Mchenry, IL. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Worthington Diagnostic Systems between 1979 and 1984. The busiest year on record is 1983, with 12. The most recent is 1984, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 12 |
| 1984 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | LKZ | Substantially Equivalent | |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | KNK | Substantially Equivalent | |
| K832749 | EASYTOUCH BUN REAGENT SET | CDQ | Substantially Equivalent | |
| K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | GJS | Substantially Equivalent | |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | KHG | Substantially Equivalent | |
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | CDT | Substantially Equivalent | |
| K831477 | DEMAND ANALYZER SYSTEM | JJE | Substantially Equivalent | |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | JPI | Substantially Equivalent | |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | JJF | Substantially Equivalent | |
| K831103 | TIA-IGM REAGENT & CALIBRATOR SETS | DFT | Substantially Equivalent | |
| K831102 | TIA-IGA REAGENT & CALIBRATOR SETS | CZP | Substantially Equivalent | |
| K831101 | TIA-IGG REAGENT & CALIBRATOR SETS | DEW | Substantially Equivalent | |
| K810997 | WORTHINGTON CK (NAC) REAGENT SET | JHS | Substantially Equivalent | |
| K802573 | SERUM T4 BY ENZYME IMMUNOASSAY | CDX | Substantially Equivalent | |
| K800028 | WORTHINGTON FLOZYME* CPK (340NM) | JHS | Substantially Equivalent | |
| K791962 | WORTHINGTON TRIGLYCERIDES REAGENT SET | JGY | Substantially Equivalent | |
| K790474 | SZAMYL 6.5 | CIJ | Substantially Equivalent | |
| K790486 | FLOZYME* URIC ACID REAGENT | KNK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- JGYColorimetric Method, Triglycerides
- JPIDevice, Hematocrit Measuring
- CIGDiazo Colorimetry, Bilirubin
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CDXRadioimmunoassay, Total Thyroxine
- LKZRed-Cell Count By Photometry
- CIJSaccharogenic, Amylase
- GJSTest, Time, Prothrombin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- KHGWhole Blood Hemoglobin Determination
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Worthington Diagnostic Systems edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Worthington Diagnostic Systems. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain