ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS— 510(k) K072204
Substantially EquivalentSiemens Medical Solutions Diagnostics
FDA 510(k) clearance K072204 for ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS, Substantially Equivalent on 2007-10-05. Applicant: Siemens Medical Solutions Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions Diagnostics
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tarrytown, NY, US
Recent devices under product code JIX
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- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K141388 — SYSTEM CALIBRATER
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
- K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
Data sourced from openFDA. This site is unofficial and independent of the FDA.