The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Neisseria Gonorrhoeae Fluoro-kit.
| Device ID | K800328 |
| 510k Number | K800328 |
| Device Name: | NEISSERIA GONORRHOEAE FLUORO-KIT |
| Classification | Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae |
| Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTH |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-12 |
| Decision Date | 1980-03-03 |