510(k) K934550 ยท LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
IMMUNOCARD MYCOPLASMA
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Sep 20, 1994 |
| Received | Sep 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2021 | Meridian Bioscience Inc The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection. Terminated |
LJZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.