MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY— 510(k) K982027

Substantially Equivalent

DiaSorin, Inc.

FDA 510(k) clearance K982027 for MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY, Substantially Equivalent on 1998-11-25. Applicant: DiaSorin, Inc..

Clearance details

Applicant: DiaSorin, Inc.
Product code: Code LFZ
Advisory panel: Microbiology
Date received: 1998-06-02
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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