510(k) K983359 ยท CZP Iga, Antigen, Antiserum, Control
IGA
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Sep 24, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of
immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the
specific antibody in the reagent, f Terminated |
CZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.