510(k) K061655 ยท LDP Colorimetry, Acetaminophen
DIMENSION VISTA FLEX REAGENT CARTRIDGES
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 10, 2006 |
| Received | Jun 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
CFR | None listed |
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
KLI | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Assays: Triglycerides (TRIG) Terminated |
CDT | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Assays: Uric Acid (URCA) Terminated |
KNK | None listed |
| Nov 25, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. Terminated |
JGJ | None listed |
| Aug 9, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086).
For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. Terminated |
LEH | None listed |
| Apr 17, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) MG Flex(R) Reagent Cartridge
The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the D Terminated |
JGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.