The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrezyme Phenytoin Kit Immunoassay.
| Device ID | K842161 |
| 510k Number | K842161 |
| Device Name: | VENTREZYME PHENYTOIN KIT IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| Applicant | VENTREX LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-07-09 |