ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)— 510(k) K170065
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K170065 for ADVIA® Chemistry Total Bilirubin_2 (TBIL_2), Substantially Equivalent on 2017-03-09. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JFM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code JFM
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K170065
K-number listed on FDA's recall record- Z-2471-2023 — Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
- Z-1539-2020 — ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170065.
Data sourced from openFDA. This site is unofficial and independent of the FDA.