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 |