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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
510(k) Number K873299
Device Name MERIFLUOR(TM)-GIARDIA
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact BRUCE A CLINTON,PHD
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact BRUCE A CLINTON,PHD
Regulation Number866.3220
Classification Product Code
GWD  
Date Received08/18/1987
Decision Date 09/16/1987
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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