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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg, Antigen, Antiserum, Control
510(k) Number K911610
Device Name ELISA COMBI-KIT HUMAN IGG SUBCLASSES
Applicant
Janssen Research Foundation
40 Kingsbridge Rd.
Piscataway,  NJ  08555
Applicant Contact RUTH WASSERMAN
Correspondent
Janssen Research Foundation
40 Kingsbridge Rd.
Piscataway,  NJ  08555
Correspondent Contact RUTH WASSERMAN
Regulation Number866.5510
Classification Product Code
DEW  
Date Received03/25/1991
Decision Date 06/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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