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Focus Diagnostics, Inc.

14 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (K152408)Focus Diagnostics, Inc.2015-09-21
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (K143651)Focus Diagnostics, Inc.2015-03-18
STRATIFY JCV DXSELECT (K120986)Focus Diagnostics, Inc.2012-08-16
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (K120413)Focus Diagnostics, Inc.2012-07-13
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (K113433)Focus Diagnostics, Inc.2012-04-04
STRATIFY JCV(TM) ANTIBODY (DEN120008)Focus Diagnostics, Inc.2012-01-20
SIMPLEXA FLU A/B & RSV (K102170)Focus Diagnostics, Inc.2010-11-24
3M INTEGRATED CYCLER (110V) & (220V) (K102314)Focus Diagnostics, Inc.2010-10-29
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (K100148)Focus Diagnostics, Inc.2010-05-24
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381)Focus Diagnostics, Inc.2008-08-04
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (K073382)Focus Diagnostics, Inc.2008-07-28
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G (K071511)Focus Diagnostics, Inc.2007-10-05
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 (K071510)Focus Diagnostics, Inc.2007-09-24
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G (K062543)Focus Diagnostics, Inc.2007-02-01

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Every clearance here is in the API, with alerts when new ones post.