DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET— 510(k) K103557

Substantially Equivalent

Diazyme Laboratories

FDA 510(k) clearance K103557 for DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET, Substantially Equivalent on 2011-04-27. Applicant: Diazyme Laboratories.

Clearance details

Applicant: Diazyme Laboratories
Product code: Code DCK
Advisory panel: Immunology
Date received: 2010-12-02
Decision date: 2011-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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