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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
510(k) Number K853307
Device Name DIRECT ELISA FOR HERPES SIMPLEX VIRUS
Applicant
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Applicant Contact TERRY L FOSTER
Correspondent
Fairleigh Dickinson Laboratories, Inc.
1249 Ambler Ave.
Abilene,  TX  79601
Correspondent Contact TERRY L FOSTER
Regulation Number866.3305
Classification Product Code
GQN  
Date Received08/07/1985
Decision Date 12/23/1985
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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