510(k) K980737 ยท GGT Assay, Erythropoietin
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Mar 23, 1999 |
| Received | Feb 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980737
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.