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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 K855034
Device Name AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
Applicant
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact BARTELS
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact BARTELS
Regulation Number864.4400
Classification Product Code
LIJ  
Date Received12/17/1985
Decision Date 03/11/1986
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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