K080057

Substantially Equivalent

IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

Applicant: Novx Systems, Inc.
Product code: DKZ
Advisory panel: Clinical Toxicology
Date received: 2008-01-09
Decision date: 2008-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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