The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrezyme Phenobarbital Kit Immuno.
| Device ID | K842264 |
| 510k Number | K842264 |
| Device Name: | VENTREZYME PHENOBARBITAL KIT IMMUNO |
| Classification | Enzyme Immunoassay, Phenobarbital |
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-07 |
| Decision Date | 1984-08-14 |