510(k) K093955 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
ANTI-HAV IGM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 22, 2010 |
| Received | Dec 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093955
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2019 | Roche Diagnostics Operations, Inc. Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma
Catalog number: 07026773190 Terminated |
LOL | None listed |
| Dec 17, 2018 | Roche Diagnostics Corporation Anti-HAV IgM test System, Material No. 11820591160
Product Usage:
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (ant Terminated |
LOL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.