510(k) K000468 ยท DBI Complement C4, Antigen, Antiserum, Control
RANDOX COMPLEMENT C4
| Applicant | Randox Laboratories, Ltd., Antrim, N. Ireland, IR |
| Decision | Substantially Equivalent, Mar 27, 2000 |
| Received | Feb 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000468
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.