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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixative, Alcohol Containing
510(k) Number K842913
Device Name WRIGHT STAIN FIXATIVE
Applicant
E K Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
E K Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
LDZ  
Date Received07/25/1984
Decision Date 09/07/1984
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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