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Focus Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K120986 STRATIFY JCV DXSELECTOYP2012-08-16 View
510(k) K120413 SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACKOCC2012-07-13 View
510(k) K113433 SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTOMN2012-04-04 View
510(k) K102170 SIMPLEXA FLU A/B & RSVOCC2010-11-24 View
510(k) K102314 3M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29 View
510(k) K100148 SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500OQW2010-05-24 View
510(k) K073381 PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MLJN2008-08-04 View
510(k) K073382 PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GLSE2008-07-28 View
510(k) K071511 PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900GMXJ2007-10-05 View
510(k) K071510 HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950MXJ2007-09-24 View
510(k) K062543 HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900GMXJ2007-02-01 View
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