ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR— 510(k) K071455
Substantially EquivalentSiemens Medical Solutions Diagnostics
FDA 510(k) clearance K071455 for ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR, Substantially Equivalent on 2008-09-11. Applicant: Siemens Medical Solutions Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions Diagnostics
- Product code
- Code MKW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1235
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code MKW
view all- K080751 — ARCHITECT CYCLOSPORINE
- K081992 — DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
- K062236 — DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
- K053061 — EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- K052017 — CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
More clearances from Siemens Medical Solutions Diagnostics
view all- K100910 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K091984 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
- K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
- K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
- K072658 — ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
Recalls naming K071455
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071455.
Data sourced from openFDA. This site is unofficial and independent of the FDA.