510(k) K060628 ยท CIG Diazo Colorimetry, Bilirubin
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 6, 2006 |
| Received | Mar 9, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Total Bilirubin Flex reagent cartridge
-In vitro Diagnostic for the determination of total bilirubin.
SMN: 10444957
Product Usage: Dimension TBI method for the clinical chemistry syst6em Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.