DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350— 510(k) K083462
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K083462 for DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350, Substantially Equivalent on 2009-02-27. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.