K083465

Substantially Equivalent

DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

Applicant: Siemens Healthcare Diagnostics
Product code: CGS
Advisory panel: Clinical Chemistry
Date received: 2008-11-24
Decision date: 2009-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Newark, DE, US

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