The following data is part of a premarket notification filed by Culture Kits, Inc. with the FDA for Goni-kit.
| Device ID | K852582 |
| 510k Number | K852582 |
| Device Name: | GONI-KIT |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | CULTURE KITS, INC. 14 PRENTICE ST. P.O. BOX 748 Norwich, NY 13815 |
| Contact | Stephanie G Pitzer |
| Correspondent | Stephanie G Pitzer CULTURE KITS, INC. 14 PRENTICE ST. P.O. BOX 748 Norwich, NY 13815 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-18 |
| Decision Date | 1985-07-12 |