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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 K820007
Device Name NEISSERIA GONORRHOEAE TEST
Applicant
New Horizons Diagnostics Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
New Horizons Diagnostics Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3390
Classification Product Code
LIC  
Date Received01/04/1982
Decision Date 01/29/1982
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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