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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kappa, Antigen, Antiserum, Control
510(k) Number K812485
Device Name DAKO PAP KIT K504
Applicant
Dako Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dako Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5550
Classification Product Code
DFH  
Date Received08/31/1981
Decision Date 02/10/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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