DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107— 510(k) K060502
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K060502 for DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107, Substantially Equivalent on 2006-05-18. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code MLM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1678
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Recalls naming K060502
K-number listed on FDA's recall record- Z-1924-2013 — Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.
- Z-0957-2013 — Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060502.
Data sourced from openFDA. This site is unofficial and independent of the FDA.