K012397 is an FDA 510(k) clearance for the URISYS 2400 URINE TEST STRIP. This device is classified as a Method, Enzymatic, Glucose (urinary, Non-quantitative) (Class II - Special Controls, product code JIL).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 26, 2001, 61 days after receiving the submission on July 27, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1340.
| 510(k) Number | K012397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2001 |
| Decision Date | September 26, 2001 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIL — Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1340 |