DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212— 510(k) K061719
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K061719 for DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212, Substantially Equivalent on 2006-08-25. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CIG
view allMore clearances from Dade Behring, Inc.
view all- K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07
- K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
- K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
- K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
- K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
Recalls naming K061719
K-number listed on FDA's recall record- Z-3065-2024 — Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
- Z-1541-2020 — 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 diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061719.
Data sourced from openFDA. This site is unofficial and independent of the FDA.