DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454— 510(k) K090236
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K090236 for DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454, Substantially Equivalent on 2009-04-27. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code LOJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- 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.