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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thyroglobulin, Antigen, Antiserum, Control
510(k) Number K953066
Device Name SERODIA ATG
Applicant
Fujirebio America, Inc.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SCJOFF
Correspondent
Fujirebio America, Inc.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SCJOFF
Regulation Number866.5870
Classification Product Code
DDC  
Date Received06/30/1995
Decision Date 08/14/1995
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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