510(k) K954191 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
SERAQUEST CMV IGG
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Feb 23, 1996 |
| Received | Sep 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954191
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.