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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Herpesvirus Hominis 1,2
510(k) Number K852360
Device Name ORTHO DNA PROBE HSV CONFIRMATION TEST
Applicant
Ortho Diagnostic Systems, Inc.
1125 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact LARRY D MCCLAIN
Correspondent
Ortho Diagnostic Systems, Inc.
1125 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact LARRY D MCCLAIN
Regulation Number866.3305
Classification Product Code
GQL  
Date Received06/04/1985
Decision Date 09/12/1985
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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