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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Immunodiffusion, Immunoglobulins (G, A, M)
510(k) Number K915650
Device Name HUMAN IGG SUBCLASS RID KIT
Applicant
Janssen Biochimica
40 Kingsbridge Rd.
Piscataway,  NJ  08855
Applicant Contact RUTH WASSERMAN
Correspondent
Janssen Biochimica
40 Kingsbridge Rd.
Piscataway,  NJ  08855
Correspondent Contact RUTH WASSERMAN
Regulation Number866.5510
Classification Product Code
CGM  
Date Received12/18/1991
Decision Date 03/26/1992
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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