510(k) K983132 ยท DFT Igm, Antigen, Antiserum, Control
IGM
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Sep 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of
immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the
specific antibody in the reagent, f Terminated |
DFT | None listed |
| Jan 11, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Immunoglobulin M, List Number 1E01-20 Terminated |
DFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.