510(k) K974552 ยท LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Jan 28, 1998 |
| Received | Dec 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2009 | Diamedix Corporation Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assess Terminated |
LJB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.