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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 K022176
Device Name ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
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 Received07/03/2002
Decision Date 12/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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