The following data is part of a premarket notification filed by Spectrum Diagnostic, Inc. with the FDA for Gonorrhea Transette 3.
| Device ID | K822886 |
| 510k Number | K822886 |
| Device Name: | GONORRHEA TRANSETTE 3 |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | SPECTRUM DIAGNOSTIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-28 |
| Decision Date | 1982-10-27 |