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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 K896918
Device Name MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact DEBORA HINMAN
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact DEBORA HINMAN
Regulation Number866.5550
Classification Product Code
DEH  
Date Received12/11/1989
Decision Date 08/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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