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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 K841434
Device Name VARICELLA-ZOSTER(IGG) IFA TEST
Applicant
Zeus Scientific, Inc.
St. John & Elizabeth St.s
Raritan,  NJ  08869 -
Applicant Contact DAVID A WALL
Correspondent
Zeus Scientific, Inc.
St. John & Elizabeth St.s
Raritan,  NJ  08869 -
Correspondent Contact DAVID A WALL
Regulation Number866.3900
Classification Product Code
GQW  
Date Received04/06/1984
Decision Date 04/19/1985
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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