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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
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modification to:roche diagnostics precinorm universal and precipath universal control sera ROCHE DIAGNOSTICS CORP. k041227 05/27/2004
cold light; cold light md; gossamer dermlight ONYX MEDICAL INC. k041679 12/16/2004
dualflex rx ercp cannula, models 4681, 4682 BOSTON SCIENTIFIC CORP. k041827 08/06/2004
radionics xknife rt 3 with non stereotactic module RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP k041997 08/27/2004
kodak color medical imager 1000 EASTMAN KODAK COMPANY k042159 09/24/2004
modification to dimension nt-probnp flex reagent cartridge method DADE BEHRING, INC. k042347 11/19/2004
adventure a10 ULRICH ALBER GMBH k042535 10/05/2004
optima mx BIEN-AIR SA SWITZERLAND k042759 10/20/2004
ameditech immutest multi-drug screen panel ii AMEDITECH, INC. k042975 12/29/2004
modification to mbcp BIOMATLANTE k043005 05/03/2005

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