ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS— 510(k) K103701
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K103701 for ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS, Substantially Equivalent on 2011-02-18. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 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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- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K141388 — SYSTEM CALIBRATER
More clearances from Siemens Healthcare Diagnostics, Inc.
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