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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K042625
Device Name QUIKREAD CRP CALIBRATOR SET
Applicant
Orion Diagnostica, OY
Koivumankkaantie 6
Espoo,  FI 02200
Applicant Contact ANNIKHA RANTAMA
Correspondent
Orion Diagnostica, OY
Koivumankkaantie 6
Espoo,  FI 02200
Correspondent Contact ANNIKHA RANTAMA
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/27/2004
Decision Date 11/18/2004
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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