510(k) K121558 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
DIAZYME HSCRP POC TEST KIT
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Sep 21, 2012 |
| Received | May 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121558
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.