510(k) K042189 ยท MZU System, Test, Sodium, Enzymatic Method
DIAZYME SODIUM ENZYMATIC ASSAY
| Applicant | Diazyme Laboratories, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 7, 2004 |
| Received | Aug 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042189
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.