510(k) K983441 ยท CZW Complement C3, Antigen, Antiserum, Control
C3
| Applicant | Abbott Laboratories, Irving TX, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Sep 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human
serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble
immune complexes. The immune comp Terminated |
CZW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.