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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Neutralization, Herpesvirus Hominis
510(k) Number K791397
Device Name HERPES EIA TEST KIT
Applicant
Microbiological Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Microbiological Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3305
Classification Product Code
GQM  
Date Received07/27/1979
Decision Date 09/24/1979
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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