510(k) K133067 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Sep 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH Triglycerides (concentrated)-In vitro diagnostic use
in the quantitative measurement of triglycerides in human serum and plasma (lithium
heparin, potassium EDTA) using the Atellica CH Anal Open, Classified |
CDT | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT Terminated |
CDT | None listed |
| Mar 7, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575.
For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemist Terminated |
CDT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.