New Horizons Diagnostics Co. - FDA 510(k) Cleared Devices

Cleared Jun 27, 1995

CHOLERA SMART(TM)

K932622 · GSQ

Microbiology · 756d

Cleared Mar 23, 1993

PYLORISCREEN

K925190 · LYR

Microbiology · 160d

Cleared Dec 07, 1992

CHOLERASCREEN

K922432 · GSQ

Microbiology · 199d

Cleared Feb 19, 1988

RAPID COLORIMETRIC DIRECT STREP A TEST

K874761 · GTZ

Microbiology · 92d

Cleared May 28, 1987

SYPHILIS SEROLOGICAL REAGENTS

K871226 · GMQ

Microbiology · 62d

Cleared May 13, 1987

THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE

K871105 · LIC

Microbiology · 55d

Cleared Jun 30, 1986

RAPID BACTERIURIA SCREEN (RBS)

K862195 · JXA

Microbiology · 21d

Cleared Jul 05, 1985

LATEX AGGLUTINATION TEST

K851132 · GTZ

Microbiology · 106d

Cleared Aug 04, 1982

IMPROVED GONO GEN

K821362 · LIC

Microbiology · 89d

Cleared Jan 29, 1982

NEISSERIA GONORRHOEAE TEST

K820007 · LIC

Microbiology · 25d