The following data is part of a premarket notification filed by Spectrum Diagnostic, Inc. with the FDA for Herpes Transette.
| Device ID | K823443 |
| 510k Number | K823443 |
| Device Name: | HERPES TRANSETTE |
| 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 | 1982-11-16 |
| Decision Date | 1982-12-03 |