The following data is part of a premarket notification filed by Dynagen, Inc. with the FDA for Uritec Test Strip & Human Urine + & - Test Control.
| Device ID | K912888 |
| 510k Number | K912888 |
| Device Name: | URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL |
| Classification | Strip, Test Isoniazid |
| Applicant | DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Contact | Peter J Mione |
| Correspondent | Peter J Mione DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Product Code | MIG |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-01 |
| Decision Date | 1992-02-24 |