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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K070824
Device Name CREATININE (ENZYMATIC)
Applicant
Thermofisher Scientific OY
2 Ratastie
Vantaa,  FI 01620
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermofisher Scientific OY
2 Ratastie
Vantaa,  FI 01620
Correspondent Contact PAIVI SORMUNEN
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Codes
JIX   JJY  
Date Received03/26/2007
Decision Date 12/03/2007
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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