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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 K890694
Device Name BETA-2 MICROGLOBULIN EIA
Applicant
Serex, Inc.
100 S. Van Brunt St.
Englewood,  NJ  07631
Applicant Contact JUDITH FITZPATRICK
Correspondent
Serex, Inc.
100 S. Van Brunt St.
Englewood,  NJ  07631
Correspondent Contact JUDITH FITZPATRICK
Regulation Number866.5630
Classification Product Code
JZG  
Date Received02/10/1989
Decision Date 03/16/1989
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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