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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
Date
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infinion 0.6t mr imaging system PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. k013858 01/22/2002
olympus ldl cholesterol reagent, olympus ldl cholesterol calibrator, olympus hdl/ldl cholesterol control sera OLYMPUS AMERICA, INC. k014032 02/08/2002
oxyarm co2 SOUTHMEDIC, INC. k014211 06/11/2002
dried gram-positive mic/combo panels with ampicillin DADE BEHRING, INC. k020160 03/14/2002
amphetamines enzyme immunoassay, catalog #0040 (500 tests kit), catalog #0041 (5000 tests kit) Lin-Zhi International, Inc. k020395 06/04/2002
bd bifurcated needle, models 301754, 301755, 301756, 301757 BD k020523 03/20/2002
digital electrical muscle stimulator, model ev-807 digital ems EVERYWAY MEDICAL INSTRUMENTS CO., LTD. k020750 10/31/2002
acist plus 4 angiographic catheter ACIST MEDICAL SYSTEMS k021015 04/26/2002
triage b-type natriuretic peptide (bnp) test BIOSITE INCORPORATED k021317 07/01/2002
96 channel eeg headbox model emu96 EXCEL TECH. LTD. k021599 08/13/2002

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