The following data is part of a premarket notification filed by Medtex Laboratories, Inc. with the FDA for Gonopox Test Kit.
| Device ID | K960759 |
| 510k Number | K960759 |
| Device Name: | GONOPOX TEST KIT |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | MEDTEX LABORATORIES, INC. 10215 LAKE CITY WAY, N.E. SUITE F Seattle, WA 98125 |
| Contact | Kirk C S. Chen |
| Correspondent | Kirk C S. Chen MEDTEX LABORATORIES, INC. 10215 LAKE CITY WAY, N.E. SUITE F Seattle, WA 98125 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-26 |
| Decision Date | 1996-09-18 |