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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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slic screw repair system ACUMED LLC k111608 08/29/2011
freestyle insulinx blood glucose monitoring systems ABBOTT LABORATORIES k111874 02/16/2012
monica if24 MONICA HEALTHCARE k112163 08/30/2011
verigene staphylococcus blood culture nucleic acid test (bc-s) NANOSPHERE, INC k112424 12/16/2011
stimulation/dissection instruments NUVASIVE, INCORPORATED k112709 02/09/2012
smart segmentation-knowledge based contouring VARIAN MEDICAL SYSTEMS k112778 12/29/2011
lzi cocaine metabolite homogeneous enzyme immunoassay,calibrators,controls Lin-Zhi International, Inc. k113139 11/22/2011
ace carbon dioxide(co2-lc) reagent, ace direct bilirubin reagent, ace total bilirubin reagent, ace magnesium reagent ALFA WASSERMANN k113435 07/02/2012
mounted medical oxygen system ESSEX INDUSTRIES, INC. k113767 06/29/2012
glycosylated hemoglobin assay; clinical chemistry BECKMAN COULTER, INC k120199 10/12/2012

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