510(k) K881064 ยท LIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
HYGEIA GC TEST
| Applicant | Hygeia Sciences, Newton MA, US |
| Decision | Substantially Equivalent, Jun 2, 1988 |
| Received | Mar 14, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881064
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.