Medical Device Manufacturer · US , Cypress , CA

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

5 submissions · 5 cleared · Since 2002

5

Total

5

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Jun 30, 2004

WEST NILE VIRUS IGM CAPTURE ELISA

Microbiology · 90d

Cleared Oct 22, 2003

WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M

Microbiology · 119d

Cleared Oct 22, 2003

WEST NILE VIRUS ELISA IGG, MODEL EL0300G

Microbiology · 119d

Cleared Aug 01, 2002

HERPESELECT 2 ELISA IGG, MODEL ELO920G

Microbiology · 90d

Cleared Jul 29, 2002

HERPESELECT 1 ELISA IGG, MODEL EL0910G

Microbiology · 87d