K061719

Substantially Equivalent

DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212

Applicant: Dade Behring, Inc.
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 2006-06-19
Decision date: 2006-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.