K090330

Substantially Equivalent

DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: JFY
Advisory panel: Clinical Chemistry
Date received: 2009-02-10
Decision date: 2009-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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