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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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sentinel ceruloplasmin SENTINEL CH. SRL k051456 10/21/2005
sentinel plasmaproteins cal 3x SENTINEL CH. SRL k051457 07/25/2005
wieslab cap pr-3 anca EURODIAGNOSTICA k051458 11/22/2005
sysmex model xe-2100dc automated hematology analyzer SYSMEX AMERICA, INC. k051459 09/23/2005
spotchem ii inoganic phosphorus, cpk and uric acid tests ARKRAY, INC. k051648 01/31/2006
vericis cardiovascular image and information system, model 4.0 CAMTRONICS MEDICAL SYSTEMS k051649 08/02/2005
stratus cs acute care mb isoenzyme of creatine kinase (ckmb) test pak; stratus cs acute care ckmb testpak. DADE BEHRING, INC. k051650 09/08/2005
g4, model igm-0004 U. S. DIAGNOSTICS, INC. k051651 04/14/2006
atlantis abutment, atlantis gemini abutment, atlantis gemini+ abutment ATLANTIS COMPONENTS, INC. k051652 07/22/2005
angiodynamics, inc., micro access kits ANGIODYNAMICS, INC. k051655 09/12/2005

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