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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Herpesvirus Hominis 1,2
510(k) Number K852928
Device Name VIROGEN HERPES SLIDE TEST
Applicant
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Applicant Contact STEPHEN C KO0LAKOWS
Correspondent
Armkel, LLC
Half Acre Rd.
P.O. Box 1001
Cranbury,  NJ  08512
Correspondent Contact STEPHEN C KO0LAKOWS
Regulation Number866.3305
Classification Product Code
GQO  
Date Received07/09/1985
Decision Date 10/17/1985
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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