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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 K842887
Device Name HERPES VIRUS AGGLUTINATION TEST
Applicant
Scientific Research
1249 Ambler
Abilene,  TX  79601 -
Applicant Contact SWAN
Correspondent
Scientific Research
1249 Ambler
Abilene,  TX  79601 -
Correspondent Contact SWAN
Regulation Number866.3305
Classification Product Code
GQO  
Date Received07/23/1984
Decision Date 02/26/1985
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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