510(k) K982529 ยท MRR System, Test, Low Density, Lipoprotein
RANDOX DIRECT LDL CHOLESTEROL
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Sep 11, 1998 |
| Received | Jul 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer.
SMN: 11097632 Open, Classified |
MRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.