The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Drug Stop.
| Device ID | K991465 |
| 510k Number | K991465 |
| Device Name: | DRUG STOP |
| Classification | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Applicant | TEXAS IMMUNOLOGY, INC. 12524 FM 3226 Tyler, TX 75707 |
| Contact | Charles W Gill |
| Correspondent | Charles W Gill TEXAS IMMUNOLOGY, INC. 12524 FM 3226 Tyler, TX 75707 |
| Product Code | MVO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-27 |
| Decision Date | 1999-12-10 |