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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Trichomonas
510(k) Number K894246
Device Name MERIVIEW TM TRICHOMONAS
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact MICHELE NICKOL
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact MICHELE NICKOL
Regulation Number866.2660
Classification Product Code
JWZ  
Date Received06/21/1989
Decision Date 08/15/1989
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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