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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, Systemic Lupus Erythematosus
510(k) Number K872910
Device Name IMMUNO/SLE
Applicant
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact KENNETH KUPITS
Correspondent
Immunostics Co., Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact KENNETH KUPITS
Regulation Number866.5820
Classification Product Code
DHC  
Date Received07/24/1987
Decision Date 08/12/1987
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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