The following data is part of a premarket notification filed by Remel Co. with the FDA for Nizyme Test Kit.
| Device ID | K923566 |
| 510k Number | K923566 |
| Device Name: | NIZYME TEST KIT |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Ann Silvius |
| Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-17 |
| Decision Date | 1992-11-02 |