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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K073612
Device Name URIC ACID (AOX), SCAL, NORTROL, ABTROL
Applicant
Thermofisher Scientific OY
2 Ratastie
P.O. Box 100
Vantaa,  FI FIN-01621
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermofisher Scientific OY
2 Ratastie
P.O. Box 100
Vantaa,  FI FIN-01621
Correspondent Contact PAIVI SORMUNEN
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Codes
JJY   KNK  
Date Received12/21/2007
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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