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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K031607
Device Name ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL
Applicant
ORION DIAGNOSTICA, DIV. ORION CORP.
KOIVU-MANKKAAN TIE 6
ESPOO,  FI 02200
Applicant Contact ANNIKKA RANTAMA
Correspondent
ORION DIAGNOSTICA, DIV. ORION CORP.
KOIVU-MANKKAAN TIE 6
ESPOO,  FI 02200
Correspondent Contact ANNIKKA RANTAMA
Regulation Number866.5270
Classification Product Code
DCK  
Date Received05/22/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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