The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ebv-vca Igm Elisa Test Ststem.
| Device ID | K944449 |
| 510k Number | K944449 |
| Device Name: | EBV-VCA IGM ELISA TEST STSTEM |
| 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 | 1994-09-12 |
| Decision Date | 1995-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027948 | K944449 | 000 |
| 04048474027945 | K944449 | 000 |