510(k) K971304 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
QUANTA LITE REBELLA IGG
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Apr 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971304
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.