510(k) K955794 ยท CZP Iga, Antigen, Antiserum, Control
IGA 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 K955794
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2022 | Randox Laboratories Ltd. IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IA3832 Terminated |
CZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.