510(k) K013152 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
| Applicant | Elan Holdings, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Sep 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013152
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.