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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 K971464
Device Name IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
Applicant
Euro-Diagnostica AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Applicant Contact KARL A POSSELT
Correspondent
Euro-Diagnostica AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Correspondent Contact KARL A POSSELT
Regulation Number866.5660
Classification Product Code
DBL  
Date Received04/22/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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