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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
510(k) Number K874078
Device Name MERITEC(TM)-GC
Applicant
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact CLINTON, PHD
Correspondent
Meridian Diagnostics, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact CLINTON, PHD
Regulation Number866.3390
Classification Product Code
LIC  
Date Received10/06/1987
Decision Date 12/09/1987
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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