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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Quality Control For Culture Media
510(k) Number K862914
Device Name FEKAL CHECK PARASITOLOGY CONTROL SLIDE
Applicant
Trend Scientific, Inc.
P.O. Box 12266
New Brighton,  MN  55112
Applicant Contact DAN TIERNEY
Correspondent
Trend Scientific, Inc.
P.O. Box 12266
New Brighton,  MN  55112
Correspondent Contact DAN TIERNEY
Regulation Number866.2480
Classification Product Code
JTR  
Date Received08/01/1986
Decision Date 09/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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