The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Hsv Igm Test.
| Device ID | K830865 |
| 510k Number | K830865 |
| Device Name: | HSV IGM TEST |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | GULL LABORATORIES, INC. 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 | 1983-03-18 |
| Decision Date | 1983-07-18 |