Focus Diagnostics, Inc. is one of 13027 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Focus Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack, Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack, STRATIFY JCV DXSELECT
14
Total
13
Cleared
1
Denied
Focus Diagnostics, Inc. has 13 FDA 510(k) cleared microbiology devices. Based in Cypress, US.
Historical record: 13 cleared submissions from 2007 to 2015.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Focus Diagnostics, Inc.
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