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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peroxidase Anti-Peroxidase Immunohistochemical Stain
510(k) Number K820336
Device Name DAKO PAP KIT K509
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 Number864.4400
Classification Product Code
LIJ  
Date Received02/08/1982
Decision Date 07/13/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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