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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K870903
Device Name IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM
Applicant
Immunomedics, Inc.
5 Bruce St., Bldg. #5
Newark,  NJ  07103
Applicant Contact NARDONE, PHD
Correspondent
Immunomedics, Inc.
5 Bruce St., Bldg. #5
Newark,  NJ  07103
Correspondent Contact NARDONE, PHD
Regulation Number866.5100
Classification Product Code
LRM  
Date Received03/05/1987
Decision Date 05/14/1987
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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