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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 K003400
Device Name CRP HS TEST SYSTEM
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250 -0457
Applicant Contact KAY A TAYLOR
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250 -0457
Correspondent Contact KAY A TAYLOR
Regulation Number866.5270
Classification Product Code
DCN  
Date Received11/01/2000
Decision Date 05/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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