FDA 510(k) Applications Submitted by FOCUS DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071510 |
06/04/2007 |
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 |
FOCUS DIAGNOSTICS, INC. |
| K073381 |
12/03/2007 |
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M |
FOCUS DIAGNOSTICS, INC. |
| K073382 |
12/03/2007 |
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G |
FOCUS DIAGNOSTICS, INC. |
| K152408 |
08/25/2015 |
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack |
FOCUS DIAGNOSTICS, INC. |
| K062543 |
08/30/2006 |
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G |
FOCUS DIAGNOSTICS, INC. |
| K113433 |
11/21/2011 |
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT |
FOCUS DIAGNOSTICS, INC. |
| K143651 |
12/23/2014 |
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack |
FOCUS DIAGNOSTICS, INC. |
| K071511 |
06/04/2007 |
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G |
FOCUS DIAGNOSTICS, INC. |
| DEN120008 |
01/06/2012 |
STRATIFY JCV(TM) ANTIBODY |
FOCUS DIAGNOSTICS, INC. |
| K100148 |
01/19/2010 |
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 |
FOCUS DIAGNOSTICS, INC. |
| K120413 |
02/10/2012 |
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK |
FOCUS DIAGNOSTICS, INC. |
| K120986 |
04/02/2012 |
STRATIFY JCV DXSELECT |
FOCUS DIAGNOSTICS, INC. |
| K102170 |
08/02/2010 |
SIMPLEXA FLU A/B & RSV |
FOCUS DIAGNOSTICS, INC. |
| K102314 |
08/16/2010 |
3M INTEGRATED CYCLER (110V) & (220V) |
FOCUS DIAGNOSTICS, INC. |
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