FERR FLEX REAGENT CARTRIDGE— 510(k) K963498
Substantially EquivalentDade Chemistry Systems, Inc.
FDA 510(k) clearance K963498 for FERR FLEX REAGENT CARTRIDGE, Substantially Equivalent on 1997-01-24. Applicant: Dade Chemistry Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Chemistry Systems, Inc.
- Product code
- Code JMG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code JMG
view allMore clearances from Dade Chemistry Systems, Inc.
view allRecalls naming K963498
K-number listed on FDA's recall record- Z-2229-2019 — Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis and iron deficiency anemia.
- Z-2238-2014 — Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
- Z-0561-2014 — Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963498.
Data sourced from openFDA. This site is unofficial and independent of the FDA.