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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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cobas integra alp ifcc gen.2 ROCHE DIAGNOSTICS CORP. k033185 10/14/2003
modification to roche elecsys folate ii immunoassay ROCHE DIAGNOSTICS CORP. k043318 12/23/2004
elecsys calcitonin; immunoassay, calset, calcheck 5; elecsys precicontrol varia 3 Roche Diagnostics k132828 12/04/2013
magnum nail ROBERT REID INC. k093089 11/13/2009
photographic equipment REZNIK INSTRUMENTS k812201 10/19/1981
vitalsense xhr RESPIRONICS, INC. k061870 08/31/2006
s9 vpap adapt, vpap adapt, aircurve 10 asv RESMED LTD k160822 09/09/2016
reprocessed depuy mitek ablation wand ReNovo, Inc. k173740 03/19/2018
randox aldolase calibration serum RANDOX LABORATORIES LIMITED k142181 09/18/2014
ali interbody fusion system Raed M. Ali, MD., Inc. k191516 09/12/2019

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