510(k) K955797 ยท DFT Igm, Antigen, Antiserum, Control
IGM IMMUNOTRUBIDIMETRIC & 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 K955797
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2022 | Randox Laboratories Ltd. IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IM3834 Terminated |
DFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.