The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Herpes I.d. Tm Test.
| Device ID | K771445 |
| 510k Number | K771445 |
| Device Name: | HERPES I.D. TM TEST |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-01 |
| Decision Date | 1977-12-14 |