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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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zeus elisa hsv gc-i igg test system ZEUS SCIENTIFIC, INC. K103363 04/26/2011
zeus elisa cardiolipin igg/igm/iga test system ZEUS SCIENTIFIC, INC. K102425 12/12/2011
zeus elisa borrelia vlse1/pepc10 igg/igm test system; zeus elisa borrelia burgdorferi igm test system ZEUS Scientific Inc. K191240 07/29/2019
zeus elisa borrelia vlse1/pepc10 igg/igm test system; zeus elisa borrelia burgdorferi igg/igm test system ZEUS Scientific, Inc. K190907 07/29/2019
zeus elisa borrelia vlse1/pepc10 igg/igm test system; zeus elisa borrelia burgdorferi igg test system ZEUS Scientific Inc. K191398 07/29/2019
zeus elisa borrelia vlse-1/pepc10 igg/igm test system ZEUS SCIENTIFIC, INC. K113397 07/26/2012
zero-click data management system, model 8000-01528 AGAMATRIX K062434 11/13/2006
zap hcg test, model 8001 ZBX CORPORATION K033297 03/18/2004
yumizen c1200, yumizen c1200 glucose hk, sodium electrode, potassium electrode, chloride electrode Horiba, Ltd K183375 02/12/2019
yumizen c1200 immunoglobulin a, yumizen c1200 immunoglobulin g, yumizen c1200 immunoglobulin m Horiba ABX SAS K193525 06/26/2020

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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