510(k) K983849 ยท JHM Colorimetric Method, Lipoproteins
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 11, 1999 |
| Received | Oct 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983849
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.