Focus Diagnostics - FDA 510(k) Cleared Devices
4
Total
3
Cleared
1
Denied
Focus Diagnostics has 3 FDA 510(k) cleared medical devices. Based in Cypress, US.
Historical record: 3 cleared submissions from 2014 to 2015. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Focus Diagnostics Filter by specialty or product code using the sidebar.
4 devices
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
Microbiology
116d