510(k) K022772 ยท MRR System, Test, Low Density, Lipoprotein
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Sep 17, 2002 |
| Received | Aug 21, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022772
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.