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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Beta-2-Microglobulin Immunological
510(k) Number K901333
Device Name BETA-2 MICROGLOBULIN EIA
Applicant
Serex, Inc.
38 Franklin St.
Tenafly,  NJ  07670
Applicant Contact CHARLES B BREUER
Correspondent
Serex, Inc.
38 Franklin St.
Tenafly,  NJ  07670
Correspondent Contact CHARLES B BREUER
Regulation Number866.5630
Classification Product Code
JZG  
Date Received03/20/1990
Decision Date 04/02/1990
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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