510(k) K063329 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
ABBOTT ARCHITECT HAVAB-M
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Apr 16, 2007 |
| Received | Nov 3, 2006 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K063329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2011 | Abbott Laboratories ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric seru Terminated |
LOL | None listed |
| May 19, 2010 | Abbott Diagnostics International, Ltd. ARCHITECT HAVAB-M Reagent
A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and Terminated |
LOL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.