The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urs-2gp (glucose Protein) Urine Strips.
| Device ID | K131600 |
| 510k Number | K131600 |
| Device Name: | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Steve Partono |
| Correspondent | Steve Partono TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-03 |
| Decision Date | 2014-05-29 |
| Summary: | summary |