510(k) K972295 ยท LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
SERAQUEST VZV IGG
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Nov 5, 1997 |
| Received | Jun 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972295
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.