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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Angiotensin Converting Enzyme
510(k) Number K041657
Device Name THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
Applicant
Thermo Electron Corporation
331 S. 104th St.
Louisville,  CO  80027
Applicant Contact BOLA NICHOLSON
Correspondent
Thermo Electron Corporation
331 S. 104th St.
Louisville,  CO  80027
Correspondent Contact BOLA NICHOLSON
Regulation Number862.1090
Classification Product Code
KQN  
Subsequent Product Codes
JIS   JJX  
Date Received06/18/2004
Decision Date 08/30/2004
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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