The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventre/sep Ige Ria Test Set.
| Device ID | K811559 |
| 510k Number | K811559 |
| Device Name: | VENTRE/SEP IGE RIA TEST SET |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-02 |
| Decision Date | 1981-07-10 |