DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306— 510(k) K081857
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K081857 for DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306, Substantially Equivalent on 2008-10-30. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code NRP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3840
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code NRP
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K081857
K-number listed on FDA's recall record- Z-1670-2018 — Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
- Z-1633-2016 — Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirolimus in whole blood on the Dimension clinical chemistry system.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081857.
Data sourced from openFDA. This site is unofficial and independent of the FDA.