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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K830865
Device Name HSV IGM TEST
Applicant
Gull Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gull Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3305
Classification Product Code
GQL  
Date Received03/18/1983
Decision Date 07/18/1983
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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