The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrezyme Eia Controls-immunoassay.
| Device ID | K833423 |
| 510k Number | K833423 |
| Device Name: | VENTREZYME EIA CONTROLS-IMMUNOASSAY |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-03 |
| Decision Date | 1983-12-08 |