510(k) K984153 ยท LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jan 11, 1999 |
| Received | Nov 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984153
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.