The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Hsv-1 And/or -2 Igm Elisa Test System.
| Device ID | K983656 |
| 510k Number | K983656 |
| Device Name: | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1999-03-18 |