510(k) K080057— IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL

Substantially Equivalent

Novx Systems, Inc.

Clearance details

Applicant: Novx Systems, Inc.
Product code: 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

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