Medical Device Manufacturer · US , Cypress , CA

Focus Diagnostics, Inc. - FDA 510(k) Cleared Devices

14 submissions · 13 cleared · Since 2007
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
1-12 of 14
Cleared Sep 21, 2015
Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
K152408 · OCC
Microbiology · 27d
Cleared Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
K143651 · PGX
Microbiology · 85d
Cleared Aug 16, 2012
STRATIFY JCV DXSELECT
K120986 · OYP
Microbiology · 136d
Cleared Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K120413 · OCC
Microbiology · 154d
Cleared Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433 · OMN
Microbiology · 135d
Not Cleared Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
DEN120008 · OYP
Microbiology · 14d
Cleared Nov 24, 2010
SIMPLEXA FLU A/B & RSV
K102170 · OCC
Microbiology · 114d
Cleared Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
K102314 · OOI
Microbiology · 74d
Cleared May 24, 2010
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
K100148 · OQW
Microbiology · 125d
Cleared Aug 04, 2008
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381 · LJN
Microbiology · 245d
Cleared Jul 28, 2008
PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
K073382 · LSE
Microbiology · 238d
Cleared Oct 05, 2007
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
K071511 · MXJ
Microbiology · 123d
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