The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrezyme T4u Immunoassay T4u.
| Device ID | K841024 |
| 510k Number | K841024 |
| Device Name: | VENTREZYME T4U IMMUNOASSAY T4U |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-05-09 |