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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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sofia (r) strep a+ fia QUIDEL CORPORATION k141775 12/16/2014
fastpack high sensitivity c-reactive protein immunoassay, high sensitivity c-reactive protein calibrator kit, fastpack high sensitivity c-reactive protein controls, fastpack high sensitivity c-reactive protein method verification kit Qualigen, Inc. k141689 01/07/2015
avs® al and align peek spacers, avs® pl and unilif peek spacers, avs® tl peek spacer, avs® navigator peek spacer, avs® aria peek spacer, acculif tl and pl cage, avs® anchor-l spacer, aero-al lumbar cage system STRYKER CORPORATION k143163 01/26/2015
thinkmed intermittent catheter with/without hydrophilic coating ThinkMed Medical Technology Co., Ltd. k142767 02/03/2015
mr810 system, 900mr810 adult single limb circuit, 900mr810e adult dual limb circuit Fisher & Paykel Healthcare Ltd k143646 03/05/2015
cook holmium laser fiber COOK INCORPORATED k133788 03/18/2015
g-premio bond GC AMERICA, INC. k143140 04/20/2015
model bt-220l and bt-220c Bistos Co., Ltd. k142799 07/09/2015
rapidfret oral fluid assay for cocaine, rapidfret oral fluid cocaine calibrator set, rapidfret oral fluid cocaine control set BIOPHOR DIAGNOSTICS, INC. k142129 07/24/2015
force triverse electrosugical device, holster, 10-foot, force triverse electrosurgical device, holster, 15-foot COVIDIEN k150735 08/04/2015

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