510(k) K001352 ยท DHC System, Test, Systemic Lupus Erythematosus
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
| Applicant | Corgenix, Inc., Westminster CO, US |
| Decision | Substantially Equivalent, Apr 9, 2001 |
| Received | Apr 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001352
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.