The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Scientific Inc., Anti-ebv Ea Igg Elisa.
| Device ID | K981120 |
| 510k Number | K981120 |
| Device Name: | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA |
| Classification | Epstein-barr Virus, Other |
| 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 | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1998-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027962 | K981120 | 000 |
| 04048474027969 | K981120 | 000 |