510(k) K000900 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
| Applicant | Elan Holdings, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 2, 2000 |
| Received | Mar 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000900
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.