510(k) K121053 ยท LPS Urinary Homocystine (Nonquantitative) Test System
DIAZYME HOMOCYSTEINE POC TEST KIT
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Jul 31, 2012 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121053
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.