510(k) K073072 ยท JHM Colorimetric Method, Lipoproteins
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Feb 21, 2008 |
| Received | Oct 31, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Assays: Direct HDL Cholesterol (AHDL) Terminated |
JHM | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Assays: Direct HDL Cholesterol (AHDL) Terminated |
JHM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.