510(k) K930272 ยท MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
HEMAGEN CHAGAS' KIT (EIA METHOD)
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, May 19, 1995 |
| Received | Jan 19, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930272
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.