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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
510(k) Number K953495
Device Name EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
Applicant
SCIMEDX CORP.
400 FORD RD.
DENVILLE,  NJ  07834
Applicant Contact THOMAS BRITTEN
Correspondent
SCIMEDX CORP.
400 FORD RD.
DENVILLE,  NJ  07834
Correspondent Contact THOMAS BRITTEN
Regulation Number866.5660
Classification Product Code
DBL  
Date Received07/26/1995
Decision Date 04/10/1996
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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