510(k) K010855 ยท DGC Ige, Antigen, Antiserum, Control
RANDOX IGE
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, May 15, 2001 |
| Received | Mar 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | Randox Laboratories Ltd. IgE Calibrator Series Terminated |
DGC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.