510(k) K041720 ยท MRR System, Test, Low Density, Lipoprotein
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Aug 25, 2004 |
| Received | Jun 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC)
Product Code: 6801728
UDI (10758750006793) Terminated |
MRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.