510(k) K911233 ยท MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
CHAGAS' IGG ELISA TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 4, 1992 |
| Received | Mar 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911233
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.