510(k) K011568 ยท JIS Calibrator, Primary
RANDOX LIPOPROTEIN
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Sep 28, 2001 |
| Received | May 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2025 | Randox Laboratories, Limited Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP3403 Open, Classified |
DFC | None listed |
| Jan 23, 2025 | Randox Laboratories, Limited Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers.
Catalog Number: LP2757 Open, Classified |
DFC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.