510(k) K964660 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
PARAMAX CHOLESTEROL REAGENT
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jun 4, 1997 |
| Received | Nov 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964660
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.