Company ยท US
Worthington Diagnostic Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1984. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIJ | Saccharogenic, Amylase | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| JGY | Colorimetric Method, Triglycerides | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| JPI | Device, Hematocrit Measuring | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| LKZ | Red-Cell Count By Photometry | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 4, 1984 | K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE Worthington Diagnostic Systems | LKZ |
| Oct 14, 1983 | K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT Worthington Diagnostic Systems | KNK |
| Oct 14, 1983 | K832749 | EASYTOUCH BUN REAGENT SET Worthington Diagnostic Systems | CDQ |
| Oct 14, 1983 | K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN Worthington Diagnostic Systems | CIG |
| Oct 14, 1983 | K832427 | EASYTOUCH TROMBOPLASTIN REAGENT Worthington Diagnostic Systems | GJS |
| Sep 26, 1983 | K832750 | EASYTOUCH HEMOGLOBIN REAGENT Worthington Diagnostic Systems | KHG |
| Sep 12, 1983 | K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET Worthington Diagnostic Systems | CDT |
| Jun 17, 1983 | K831477 | DEMAND ANALYZER SYSTEM Worthington Diagnostic Systems | JJE |
| Jun 8, 1983 | K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM Worthington Diagnostic Systems | JPI |
| Jun 2, 1983 | K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- Worthington Diagnostic Systems | JJF |
| Apr 27, 1983 | K831103 | TIA-IGM REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems | DFT |
| Apr 27, 1983 | K831102 | TIA-IGA REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems | CZP |
| Apr 27, 1983 | K831101 | TIA-IGG REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems | DEW |
| Apr 23, 1981 | K810997 | WORTHINGTON CK (NAC) REAGENT SET Worthington Diagnostic Systems | JHS |
| Nov 24, 1980 | K802573 | SERUM T4 BY ENZYME IMMUNOASSAY Worthington Diagnostic Systems | CDX |
| Jan 21, 1980 | K800028 | WORTHINGTON FLOZYME* CPK (340NM) Worthington Diagnostic Systems | JHS |
| Nov 5, 1979 | K791962 | WORTHINGTON TRIGLYCERIDES REAGENT SET Worthington Diagnostic Systems | JGY |
| May 1, 1979 | K790474 | SZAMYL 6.5 Worthington Diagnostic Systems | CIJ |
| Apr 23, 1979 | K790486 | FLOZYME* URIC ACID REAGENT Worthington Diagnostic Systems | KNK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||