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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Chemical Solution
510(k) Number K860319
Device Name MEGACOLOR
Applicant
Cytocolor, Inc.
P.. Box 401
Hinckley,  OH  44233
Applicant Contact KASS, M.D.
Correspondent
Cytocolor, Inc.
P.. Box 401
Hinckley,  OH  44233
Correspondent Contact KASS, M.D.
Regulation Number864.1850
Classification Product Code
LED  
Date Received01/28/1986
Decision Date 02/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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