The following data is part of a premarket notification filed by Uridynamics, Inc. with the FDA for Stoneguard Ii Reagent Strips For Urinalysis And Confirm Control Solutions.
| Device ID | K030650 |
| 510k Number | K030650 |
| Device Name: | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| Applicant | URIDYNAMICS, INC. 6786 HAWTHORNE PARK DR. Indianapolis, IN 46220 |
| Contact | Myron Rapkin |
| Correspondent | Myron Rapkin URIDYNAMICS, INC. 6786 HAWTHORNE PARK DR. Indianapolis, IN 46220 |
| Product Code | CEN |
| Subsequent Product Code | JJW |
| Subsequent Product Code | JRE |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-28 |
| Decision Date | 2003-04-14 |
| Summary: | summary |