KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT— 510(k) K072135

Name: FDA 510(k) clearance K072135
Creator: U.S. Food and Drug Administration
Published: 2007-11-07

Substantially Equivalent

Kronus Market Development Associates, Inc.

FDA 510(k) clearance K072135 for KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT, Substantially Equivalent on 2007-11-07. Applicant: Kronus Market Development Associates, Inc.. Device class: 2.

Clearance details

Applicant: Kronus Market Development Associates, Inc.
Product code: Code NWG
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2007-08-02
Decision date: 2007-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boise, ID, US

Download summary PDF View on FDA.gov ↗

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