510(k) K890023 ยท LBR Ldl & Vldl Precipitation, Hdl
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 17, 1989 |
| Received | Jan 4, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890023
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.