The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Neisseria-kwik.
| Device ID | K811412 |
| 510k Number | K811412 |
| Device Name: | NEISSERIA-KWIK |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | WINDSOR LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-19 |
| Decision Date | 1981-06-16 |