510(k) K032012 ยท LPS Urinary Homocystine (Nonquantitative) Test System
HOMOCYSTEINE MICROTITER PLATE ASSAY
| Applicant | Diazyme Laboratories, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 3, 2003 |
| Received | Jun 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032012
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.