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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K861362
Device Name IMMUNOMEDICS SERUM ELISA TEST SYSTEM
Applicant
Immunomedics, Inc.
5 Bruce St., Bldg. #5
Newark,  NJ  07103
Applicant Contact RECKEL PH.D.
Correspondent
Immunomedics, Inc.
5 Bruce St., Bldg. #5
Newark,  NJ  07103
Correspondent Contact RECKEL PH.D.
Regulation Number866.5240
Classification Product Code
CZW  
Date Received04/10/1986
Decision Date 06/06/1986
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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