510(k) K982767 ยท JIX Calibrator, Multi-Analyte Mixture
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
| Applicant | Raichem, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 21, 1998 |
| Received | Aug 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982767
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.