510(k) K983289 ยท DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
APOLIPOPROTEIN A1
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jan 29, 1999 |
| Received | Sep 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983289
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of
apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in th Terminated |
DER | None listed |
| Jan 11, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Apolipoprotein A1, List Number 9D92-20 Terminated |
DER | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.