K141689

Substantially Equivalent

FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit

Applicant: Qualigen, Inc.
Product code: DCK
Advisory panel: Immunology
Date received: 2014-06-23
Decision date: 2015-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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