Medical Device Manufacturer · US , Cypress , CA

Focus Diagnostics - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2014

Recent clearances: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack, Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack, SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK

4

Total

3

Cleared

1

Denied

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

4 devices

1-4 of 4

Cleared Aug 28, 2015

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

Microbiology · 140d

Cleared Dec 05, 2014

Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack

Microbiology · 102d

Cleared Jul 01, 2014

SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK

Microbiology · 29d

Not Cleared Mar 21, 2014

SIMPLEXA HSV 1&2 DIRECT

DEN130049 · PGH

Microbiology · 116d