K083579

Substantially Equivalent

DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

Applicant: Siemens Healthcare Diagnostics
Product code: JIX
Advisory panel: Clinical Chemistry
Date received: 2008-12-04
Decision date: 2009-02-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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