Focus Diagnostics, Inc. - FDA 510(k) Cleared Devices
14
Total
13
Cleared
1
Denied
14 devices
Cleared
Sep 21, 2015
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
Microbiology
27d
Cleared
Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
Microbiology
85d
Cleared
Aug 16, 2012
STRATIFY JCV DXSELECT
Microbiology
136d
Cleared
Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
Microbiology
154d
Cleared
Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
Microbiology
135d
Not Cleared
Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
Microbiology
14d
Cleared
Nov 24, 2010
SIMPLEXA FLU A/B & RSV
Microbiology
114d
Cleared
Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
Microbiology
74d
Cleared
May 24, 2010
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
Microbiology
125d
Cleared
Aug 04, 2008
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
Microbiology
245d
Cleared
Jul 28, 2008
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
Microbiology
238d
Cleared
Oct 05, 2007
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
Microbiology
123d
Cleared
Sep 24, 2007
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
Microbiology
112d
Cleared
Feb 01, 2007
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
Microbiology
155d