510(k) K032936 ยท JIX Calibrator, Multi-Analyte Mixture
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
| Applicant | Stanbio Laboratory, Boerne TX, US |
| Decision | Substantially Equivalent, Mar 12, 2004 |
| Received | Sep 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032936
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.