510(k) K983281 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
APOB
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Jan 26, 1999 |
| Received | Sep 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of
apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine
with apolipoprotein B in the sa Terminated |
DFC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.