510(k) K984303 ยท LBR Ldl & Vldl Precipitation, Hdl
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 28, 1999 |
| Received | Dec 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984303
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.