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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 K871105
Device Name THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE
Applicant
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Applicant Contact DAVID TRUDIL
Correspondent
New Horizons Diagnostics Co.
9110 Red Branch Rd.
Suite B
Columbia,  MD  21045
Correspondent Contact DAVID TRUDIL
Regulation Number866.3390
Classification Product Code
LIC  
Date Received03/19/1987
Decision Date 05/13/1987
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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