The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Vzv Igg Elisa Test System.
| Device ID | K961012 |
| 510k Number | K961012 |
| Device Name: | VZV IGG ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| 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 | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-13 |
| Decision Date | 1996-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239028082 | K961012 | 000 |
| 04048474028089 | K961012 | 000 |