The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Vzv Bio-enzabead Screen Kit.
| Device ID | K833637 |
| 510k Number | K833637 |
| Device Name: | VZV BIO-ENZABEAD SCREEN KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Applicant | BIONETIC LABORATORY PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-17 |
| Decision Date | 1984-02-10 |