510(k) K991789 ยท LBR Ldl & Vldl Precipitation, Hdl
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
| Applicant | Elan Holdings, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jul 9, 1999 |
| Received | May 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991789
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.