510(k) K982485 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
SERAQUEST CMV IGM
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Jan 13, 1999 |
| Received | Jul 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2022 | Bio-Rad Laboratories, Inc. CMV IgM EIA, in vitro diagnostic. Open, Classified |
LFZ | None listed |
| Jan 23, 2012 | Quest International, Inc. SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Terminated |
LKQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.