K152835 is an FDA 510(k) clearance for the URITEK TC-201 URINE CHEMISTRY TEST SYSTEM. This device is classified as a Enzymatic Method, Creatinine (Class II - Special Controls, product code JFY).
Submitted by Teco Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on March 7, 2016, 160 days after receiving the submission on September 29, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K152835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2015 |
| Decision Date | March 07, 2016 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |