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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Varicella-Zoster
510(k) Number K841526
Device Name ORTHO VARICELLA-ZOSTER VIRUS IDENT.
Applicant
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Correspondent
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Regulation Number866.3900
Classification Product Code
GQX  
Date Received04/12/1984
Decision Date 06/25/1984
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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