The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Dryside Neisseria.
| Device ID | K954784 |
| 510k Number | K954784 |
| Device Name: | DRYSIDE NEISSERIA |
| Classification | Test Reagents, Neisseria Gonorrhoeae Biochemical |
| Applicant | DIFCO LABORATORIES, INC. 17197 N. LAUREL PARK SUITE 400 Livouia, MI 48152 |
| Contact | David W Gates |
| Correspondent | David W Gates DIFCO LABORATORIES, INC. 17197 N. LAUREL PARK SUITE 400 Livouia, MI 48152 |
| Product Code | LTS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-17 |
| Decision Date | 1996-01-30 |