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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 K012518
Device Name TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
Applicant
Thermo Dma, Inc.
845 Ave. G E.
Arlington,  TX  76011
Applicant Contact THOMAS DOLLAR
Correspondent
Thermo Dma, Inc.
845 Ave. G E.
Arlington,  TX  76011
Correspondent Contact THOMAS DOLLAR
Regulation Number862.1050
Classification Product Code
CJE  
Date Received08/06/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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