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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K073191
Device Name ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
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 Number862.1050
Classification Product Code
CJE  
Subsequent Product Codes
JIX   JIY  
Date Received11/13/2007
Decision Date 02/28/2008
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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