New Horizons Diagnostics Co.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K932622 | CHOLERA SMART(TM) | June 27, 1995 |
| K925190 | PYLORISCREEN | March 23, 1993 |
| K922432 | CHOLERASCREEN | December 7, 1992 |
| K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST | February 19, 1988 |
| K871226 | SYPHILIS SEROLOGICAL REAGENTS | May 28, 1987 |
| K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | May 13, 1987 |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | June 30, 1986 |
| K851132 | LATEX AGGLUTINATION TEST | July 5, 1985 |
| K821362 | IMPROVED GONO GEN | August 4, 1982 |
| K820007 | NEISSERIA GONORRHOEAE TEST | January 29, 1982 |