Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Worthington Diagnostic Systems — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
76 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833708 | COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE | Worthington Diagnostic Systems | 1984-01-04 | 76 | 0 |
| K832749 | EASYTOUCH BUN REAGENT SET | Worthington Diagnostic Systems | 1983-10-14 | 60 | 0 |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | Worthington Diagnostic Systems | 1983-10-14 | 84 | 0 |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | Worthington Diagnostic Systems | 1983-10-14 | 59 | 0 |
| K832748 | COMPUR* EASYTOUCH TOTAL BILIRUBIN | Worthington Diagnostic Systems | 1983-10-14 | 60 | 0 |
| K832750 | EASYTOUCH HEMOGLOBIN REAGENT | Worthington Diagnostic Systems | 1983-09-26 | 42 | 0 |
| K832426 | EASYTOUCH TRIGLYCERIDES REAGENT SET | Worthington Diagnostic Systems | 1983-09-12 | 52 | 0 |
| K831477 | DEMAND ANALYZER SYSTEM | Worthington Diagnostic Systems | 1983-06-17 | 39 | 0 |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Worthington Diagnostic Systems | 1983-06-08 | 47 | 0 |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | Worthington Diagnostic Systems | 1983-06-02 | 48 | 0 |
| K831101 | TIA-IGG REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | 22 | 0 |
| K831103 | TIA-IGM REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | 22 | 0 |
| K831102 | TIA-IGA REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | 22 | 0 |
| K810997 | WORTHINGTON CK (NAC) REAGENT SET | Worthington Diagnostic Systems | 1981-04-23 | 10 | 0 |
| K802573 | SERUM T4 BY ENZYME IMMUNOASSAY | Worthington Diagnostic Systems | 1980-11-24 | 38 | 0 |
| K800028 | WORTHINGTON FLOZYME* CPK (340NM) | Worthington Diagnostic Systems | 1980-01-21 | 14 | 0 |
| K791962 | WORTHINGTON TRIGLYCERIDES REAGENT SET | Worthington Diagnostic Systems | 1979-11-05 | 35 | 0 |
| K790474 | SZAMYL 6.5 | Worthington Diagnostic Systems | 1979-05-01 | 57 | 0 |
| K790486 | FLOZYME* URIC ACID REAGENT | Worthington Diagnostic Systems | 1979-04-23 | 42 | 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