The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for The Gonogen Ii Test Kit For Neisseria Gonorrhoeae.
| Device ID | K871105 |
| 510k Number | K871105 |
| Device Name: | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Contact | David Trudil |
| Correspondent | David Trudil NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-19 |
| Decision Date | 1987-05-13 |