510(k) K915493 ยท MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
PREMIER COCCIDIOIDES
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 10, 1992 |
| Received | Dec 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915493
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.