510(k) K040767 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 7, 2004 |
| Received | Mar 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040767
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.