510(k) K001398 ยท DHC System, Test, Systemic Lupus Erythematosus
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Mar 30, 2001 |
| Received | May 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001398
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.