PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT— 510(k) K020823

Name: FDA 510(k) clearance K020823
Creator: U.S. Food and Drug Administration
Published: 2002-05-14

Substantially Equivalent

Sanquin Blood Supply Foundation

FDA 510(k) clearance K020823 for PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT, Substantially Equivalent on 2002-05-14. Applicant: Sanquin Blood Supply Foundation. Device class: 2.

Clearance details

Applicant: Sanquin Blood Supply Foundation
Product code: Code DFZ
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2002-03-14
Decision date: 2002-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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