510(k) K033610 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
HDL-CHOLESTEROL PLUS 2ND GENERATION
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 5, 2003 |
| Received | Nov 17, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033610
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.