New Horizons Diagnostics Co.
Medical device manufacturer in Columbia, MD.
10510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K932622 | Cholera Smart(Tm)GSQ · Traditional | 06/27/1995SE |
| K925190 | PyloriscreenLYR · Traditional | 03/23/1993SE |
| K922432 | CholerascreenGSQ · Traditional | 12/07/1992SE |
| K874761 | Rapid Colorimetric Direct Strep a TestGTZ · Traditional | 02/19/1988SE |
| K871226 | Syphilis Serological ReagentsGMQ · Traditional | 05/28/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | 05/13/1987SE |
| K862195 | Rapid Bacteriuria Screen (RBS)JXA · Traditional | 06/30/1986SE |
| K851132 | Latex Agglutination TestGTZ · Traditional | 07/05/1985SE |
| K821362 | Improved Gono GenLIC · Traditional | 08/04/1982SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | 01/29/1982SE |