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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K965022
Device Name MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact BRET A COOK
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact BRET A COOK
Regulation Number866.5550
Classification Product Code
DEH  
Date Received12/16/1996
Decision Date 11/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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