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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K083444
Device Name C-REACTIVE PROTEIN (LATEX)
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianaoplis,  IN  46250 -0416
Applicant Contact KATHIE J GOODWIN
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianaoplis,  IN  46250 -0416
Correspondent Contact KATHIE J GOODWIN
Regulation Number866.5270
Classification Product Code
DCN  
Date Received11/21/2008
Decision Date 03/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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