DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE— 510(k) K083465
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K083465 for DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2009-02-27. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code CGS
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newark, DE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.