The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Elisa Hsv Gc-i Igg Test System.
| Device ID | K103363 |
| 510k Number | K103363 |
| Device Name: | ZEUS ELISA HSV GC-I IGG TEST SYSTEM |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Ewa Nadolczak |
| Correspondent | Ewa Nadolczak ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-04-26 |