The following data is part of a premarket notification filed by Spectrum Diagnostic, Inc. with the FDA for Gonorrhea Transette 1 & 3.
| Device ID | K831579 |
| 510k Number | K831579 |
| Device Name: | GONORRHEA TRANSETTE 1 & 3 |
| Classification | System, Transport, Aerobic |
| Applicant | SPECTRUM DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-17 |
| Decision Date | 1983-06-17 |