DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH— 510(k) K063351

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K063351 for DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH, Substantially Equivalent on 2007-01-22. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code NDY
Advisory panel: Clinical Chemistry
Date received: 2006-11-06
Decision date: 2007-01-22
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.