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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Parasite Concentration
510(k) Number K860034
Device Name PARA-PAK MACRO-CON
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact MICHELE M NICKOL
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact MICHELE M NICKOL
Regulation Number866.2900
Classification Product Code
LKS  
Date Received01/06/1986
Decision Date 02/21/1986
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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