510(k) K961204 ยท LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
MUMPS IGG TEST
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jul 18, 1996 |
| Received | Mar 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961204
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2012 | Zeus Scientific, Inc. AtheNA Multi-Lyte MMV Test System- A93111G
A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheN Terminated |
LJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.