510(k) K071971 ยท LPS Urinary Homocystine (Nonquantitative) Test System
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Sep 17, 2007 |
| Received | Jul 17, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071971
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.