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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K883939
Device Name ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
Applicant
Ortho Diagnostic Systems, Inc.
1125 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact LARRY D MCCLAIN,PHD
Correspondent
Ortho Diagnostic Systems, Inc.
1125 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact LARRY D MCCLAIN,PHD
Regulation Number866.3830
Classification Product Code
LIP  
Date Received09/19/1988
Decision Date 12/22/1988
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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