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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 
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zymutest hia iggam, zymutest igg, model rk040d, rk040a HYPHEN BIOMED K071255 09/07/2007
zeus solinas borrelia vlse1/pepc10 igg/igm test system; zeus solinas borrelia vlse1/pepc10 igg/igm control kit ZEUS Scientific K230863 07/13/2023
zeus scientific, inc., athena multi-lyte tpo/tg igg test system ZEUS SCIENTIFIC, INC. K033977 03/22/2004
zeus scientific, inc., athena multi-lyte mpo/pr3 igg test system ZEUS SCIENTIFIC, INC. K040111 04/05/2004
zeus scientific, inc., athena multi-lyte mmrv igg test system. ZEUS SCIENTIFIC, INC. K051484 12/05/2005
zeus scientific, inc. treponema pallidum igg test system ZEUS SCIENTIFIC, INC. K102283 02/10/2011
zeus scientific, inc vzv igm elisa test system ZEUS SCIENTIFIC, INC. K070317 07/05/2007
zeus ifa(tm) ndna test system, zeus difine ZEUS Scientific K231616 08/31/2023
zeus ifa ana hep-2 test system, zeus difine Zeus Scientific, Inc. K201956 04/29/2022
zeus elisa hsv gg-2 igg test system ZEUS SCIENTIFIC, INC. K103603 05/20/2011

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