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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 K022690
Device Name PAROS CRP
Applicant
Horiba, Ltd.
34 Bunsen Dr.
Irvine,  CA  92618
Applicant Contact IAN GILES
Correspondent
Horiba, Ltd.
34 Bunsen Dr.
Irvine,  CA  92618
Correspondent Contact IAN GILES
Regulation Number866.5270
Classification Product Code
DCN  
Date Received08/13/2002
Decision Date 12/23/2002
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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