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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
510(k) Number K043125
Device Name ORION DIAGNOSTICA UNIQ PINP RIA
Applicant
Orion Diagnostica, OY
Koivumankkaantie 6
Espoo,  FI 02200
Applicant Contact ANNIKKA RANTAMA
Correspondent
Orion Diagnostica, OY
Koivumankkaantie 6
Espoo,  FI 02200
Correspondent Contact ANNIKKA RANTAMA
Regulation Number862.1050
Classification Product Code
CIN  
Date Received11/12/2004
Decision Date 05/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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