ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT— 510(k) K133067
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K133067 for ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT, Substantially Equivalent on 2013-11-22. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CDT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code CDT
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K133067
K-number listed on FDA's recall record- Z-1270-2023 — 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 Analyzer SMN: 11097591
- Z-1657-2016 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
- Z-1670-2016 — 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 Chemistry systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133067.
Data sourced from openFDA. This site is unofficial and independent of the FDA.