510(k) K023947 ยท LIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
GC OIA
| Applicant | Thermo Biostar, Inc., Louisville CO, US |
| Decision | Substantially Equivalent, Apr 17, 2003 |
| Received | Nov 27, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023947
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.