The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Neisseria Gonorrhoeae Test.
| Device ID | K820007 |
| 510k Number | K820007 |
| Device Name: | NEISSERIA GONORRHOEAE TEST |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-04 |
| Decision Date | 1982-01-29 |