510(k) K212221 ยท DHA System, Test, Human Chorionic Gonadotropin
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Dec 13, 2021 |
| Received | Jul 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212221
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.