510(k) K000661 ยท JZJ Prealbumin, Antigen, Antiserum, Control
RANDOX PREALBUMIN
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Apr 13, 2000 |
| Received | Feb 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000661
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.