510(k) K963054 ยท LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
| Applicant | Genbio, San Diego CA, US |
| Decision | Substantially Equivalent, May 5, 1997 |
| Received | Aug 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963054
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.