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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1q, Antigen, Antiserum, Control
510(k) Number K821806
Device Name ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
Applicant
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013 -
Correspondent
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013 -
Regulation Number866.5240
Classification Product Code
DAK  
Date Received06/17/1982
Decision Date 06/25/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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