The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Improved Gono Gen.
| Device ID | K821362 |
| 510k Number | K821362 |
| Device Name: | IMPROVED GONO GEN |
| Classification | Antiserum, Coagglutination (direct) Neisseria Gonorrhoeae |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. MD |
| Product Code | LIC |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-07 |
| Decision Date | 1982-08-04 |