510(k) K161646 ยท CGN Acid, Folic, Radioimmunoassay
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | Jun 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161646
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.