510(k) K971620 ยท LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
QUANTA LITE RUBEOLA (MEASLES) IGG
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 22, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971620
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.