The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Hsv-2 Elisa Test System.
| Device ID | K891782 |
| 510k Number | K891782 |
| Device Name: | HSV-2 ELISA TEST SYSTEM |
| Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Jerry W Pickering |
| Correspondent | Jerry W Pickering ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | GQL |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-06-20 |