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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), Varicella-Zoster
510(k) Number K903882
Device Name VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
Applicant
Viral Antigens, Inc.
5171 Wilfong Rd.
Memphis,  TN  38134
Applicant Contact PATRICK J CULLEY
Correspondent
Viral Antigens, Inc.
5171 Wilfong Rd.
Memphis,  TN  38134
Correspondent Contact PATRICK J CULLEY
Regulation Number866.3900
Classification Product Code
GQW  
Date Received08/22/1990
Decision Date 12/04/1990
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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