Medical Device Manufacturer · US , Cypress , CA

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

14 submissions · 13 cleared · Since 2007

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

FDA 510(k) Regulatory Record - Focus Diagnostics, Inc. Microbiology ✕

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

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

DEN120008 · OYP

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