The following data is part of a premarket notification filed by Elsohly Labs, Inc. with the FDA for Eli Urine Controls.
| Device ID | K951817 |
| 510k Number | K951817 |
| Device Name: | ELI URINE CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | ELSOHLY LABS, INC. 5 INDUSTRIAL PARK DR. Oxford, MS 38655 |
| Contact | Mahmoud A Elsohly |
| Correspondent | Mahmoud A Elsohly ELSOHLY LABS, INC. 5 INDUSTRIAL PARK DR. Oxford, MS 38655 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1995-06-19 |