New Horizons Diagnostics Co.
FDA 510(k) & PMA Approved Devices — 10 products
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Total Devices10
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K932622 | CHOLERA SMART(TM) | GSQ | 1995-06-27 | View |
| 510(k) | K925190 | PYLORISCREEN | LYR | 1993-03-23 | View |
| 510(k) | K922432 | CHOLERASCREEN | GSQ | 1992-12-07 | View |
| 510(k) | K874761 | RAPID COLORIMETRIC DIRECT STREP A TEST | GTZ | 1988-02-19 | View |
| 510(k) | K871226 | SYPHILIS SEROLOGICAL REAGENTS | GMQ | 1987-05-28 | View |
| 510(k) | K871105 | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | LIC | 1987-05-13 | View |
| 510(k) | K862195 | RAPID BACTERIURIA SCREEN (RBS) | JXA | 1986-06-30 | View |
| 510(k) | K851132 | LATEX AGGLUTINATION TEST | GTZ | 1985-07-05 | View |
| 510(k) | K821362 | IMPROVED GONO GEN | LIC | 1982-08-04 | View |
| 510(k) | K820007 | NEISSERIA GONORRHOEAE TEST | LIC | 1982-01-29 | View |
No matching devices.
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