Company ยท US
New Horizons Diagnostics Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 1995. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 1995 | K932622 | CHOLERA SMART(TM) New Horizons Diagnostics Co. | GSQ |
| Mar 23, 1993 | K925190 | PYLORISCREEN New Horizons Diagnostics Co. | LYR |
| Dec 7, 1992 | K922432 | CHOLERASCREEN New Horizons Diagnostics Co. | GSQ |
| Feb 19, 1988 | K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST New Horizons Diagnostics Co. | GTZ |
| May 28, 1987 | K871226 | SYPHILIS SEROLOGICAL REAGENTS New Horizons Diagnostics Co. | GMQ |
| May 13, 1987 | K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE New Horizons Diagnostics Co. | LIC |
| Jun 30, 1986 | K862195 | RAPID BACTERIURIA SCREEN (RBS) New Horizons Diagnostics Co. | JXA |
| Jul 5, 1985 | K851132 | LATEX AGGLUTINATION TEST New Horizons Diagnostics Co. | GTZ |
| Aug 4, 1982 | K821362 | IMPROVED GONO GEN New Horizons Diagnostics Co. | LIC |
| Jan 29, 1982 | K820007 | NEISSERIA GONORRHOEAE TEST New Horizons Diagnostics Co. | LIC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||