510(k) K955798 ยท DEW Igg, Antigen, Antiserum, Control
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Apr 5, 1996 |
| Received | Dec 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955798
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.