510(k) K010030 ยท JIX Calibrator, Multi-Analyte Mixture
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
| Applicant | Synergent Biochem Inc.-Clinical Controls Div., Hawaiian Gardens CA, US |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Jan 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010030
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.