510(k) K991274 ยท LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
MUMPS IGG ELISA TEST SYSTEM
| Applicant | Columbia Bioscience, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Apr 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2018 | Diamedix Corporation Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540 Terminated |
LJY | None listed |
| Oct 20, 2014 | Diamedix Corporation Diamedix Is-Mumps IgG Test Kit
Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of M Terminated |
LJY | None listed |
| Feb 23, 2006 | Diasorin Inc. The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1). Terminated |
LJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.