510(k) K061719 ยท CIG Diazo Colorimetry, Bilirubin
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 25, 2006 |
| Received | Jun 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146; Open, Classified |
CIG | None listed |
| Feb 13, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Total Bilirubin Flex reagent cartridge
-In vitro Diagnostic for the determination of total bilirubin.
SMN: 10445146
Product Usage: Dimension Vista TBIL method is an in vitro diagnos Terminated |
CIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.