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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg (Gamma Chain Specific), Antigen, Antiserum, Control
510(k) Number K020823
Device Name PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
Applicant
Sanquin Blood Supply Foundation
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Sanquin Blood Supply Foundation
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number866.5510
Classification Product Code
DFZ  
Date Received03/14/2002
Decision Date 05/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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