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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 K920370
Device Name ISOTYPES HUMAN IGG SUBCLASS EIA KIT
Applicant
Isotypes, Inc.
P.O. Box 7022
Newark,  DE  19714
Applicant Contact BARRY F CRISPIN
Correspondent
Isotypes, Inc.
P.O. Box 7022
Newark,  DE  19714
Correspondent Contact BARRY F CRISPIN
Regulation Number866.5510
Classification Product Code
CGM  
Date Received01/28/1992
Decision Date 03/11/1992
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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