510(k) K983356 ยท DBI Complement C4, Antigen, Antiserum, Control
C4
| 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 K983356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human
serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent,
forming an immune complex. Th Terminated |
DBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.