The following data is part of a premarket notification filed by Teco Diagnostics, Inc. with the FDA for Teco Creatinine Enzymatic Reagent Kit.
| Device ID | K161527 |
| 510k Number | K161527 |
| Device Name: | Teco Creatinine Enzymatic Reagent Kit |
| Classification | Enzymatic Method, Creatinine |
| Applicant | TECO DIAGNOSTICS, INC. 1268 NORTH LAKEVIEW AVENUE Anaheim, CA 92807 |
| Contact | Xiaoyan Hu |
| Correspondent | Xiaoyan Hu TECO DIAGNOSTICS, INC. 1268 NORTH LAKEVIEW AVENUE Anaheim, CA 92807 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2017-07-21 |
| Summary: | summary |