510(k) K011128 ยท CIB Radioimmunoassay, Angiotensin I And Renin
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
| Applicant | Nichols Institute Diagnostics, San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Sep 6, 2001 |
| Received | Apr 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011128
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.