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

Name: FDA 510(k) clearance K080057
Creator: U.S. Food and Drug Administration
Published: 2008-10-31

Substantially Equivalent

Novx Systems, Inc.

FDA 510(k) clearance K080057 for IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL, Substantially Equivalent on 2008-10-31. Applicant: Novx Systems, Inc.. Device class: 2.

Clearance details

Applicant: Novx Systems, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
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 ↗

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