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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent, Chlamydia Trachomatis
510(k) Number K853738
Device Name ORTHO CHLAMYDIA DIRECT DETECTION (FA) 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 Number866.3120
Classification Product Code
LJP  
Date Received09/06/1985
Decision Date 12/06/1985
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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